Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195176
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-12-22
Brief Title:
Randomized Clinical Trial Effect of an Exercise Routine on Postoperative Shoulder Pain in Laparoscopic Hysterectomy
Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Organization:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study Overview
Official Title:
Randomized Clinical Trial Effect of an Exercise Routine on Postoperative Shoulder Pain in Total Laparoscopic Hysterectomy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERPOSP
Brief Summary:
This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy
Main Questions
1 Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain
Brief Explanation We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders This kind of pain can happen because of the gas used during the surgery Using exercises could be a cost-effective and easy way to help patients recover better after the surgery
Hypothesis We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery
Objective Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy
How Well Do It This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain Patients selected based on specific inclusion and exclusion criteria will be randomly assigned to either the shoulder or hand exercise group The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period except at night Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively The study controls for several variables including visceral and incisional pain duration of pneumoperitoneum analgesic use and patient characteristics like BMI and comorbidities to ensure a comprehensive understanding of the exercises effectiveness The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy
Main Questions
1 Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain
Brief Explanation We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders This kind of pain can happen because of the gas used during the surgery Using exercises could be a cost-effective and easy way to help patients recover better after the surgery
Hypothesis We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery
Objective Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy
How Well Do It This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain Patients selected based on specific inclusion and exclusion criteria will be randomly assigned to either the shoulder or hand exercise group The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period except at night Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively The study controls for several variables including visceral and incisional pain duration of pneumoperitoneum analgesic use and patient characteristics like BMI and comorbidities to ensure a comprehensive understanding of the exercises effectiveness The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy
Detailed Description:
Main Objective
To evaluate the effect of a shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy at the National Institute of Perinatology
Specific Objectives
1 Describe the frequency and intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy
2 Determine the effect of the shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy
3 Evaluate the adjusted effect of the proposed intervention on pain after identifying potential confounding variables Postoperative management will be similar in both intervention groups so we do not expect to make adjustments In the event that confounding variables are identified we will address them accordingly
Hypothesis
H0 Null Hypothesis Shoulder exercises in the postoperative period do not reduce shoulder pain by at least one point on the Visual Analog Scale compared to a hand exercise routine
Description of the Procedure
Only patients scheduled for surgery at 800 AM will be considered to ensure that the exercise routine has a consistent duration for all patients during the postoperative period Inclusion criteria involve patients receiving mixed anesthesia and all patients will be positioned on the surgical table with shoulder pads and a hip angulation of 15 degrees with inflatable leg supports Patients with negative pressure drains will be excluded from the study The principal investigator will be blinded to the randomization group and patient assessments will be conducted by another investigator
Once a patient agrees to participate in the project and signs the informed consent authorization they will be randomized into one of the treatment groups Randomization will be done using opaque sealed envelopes contained in a box Each envelope will specify the assigned intervention group An equal number of envelopes for both intervention groups will be prepared in advance and shuffled Patients will choose an envelope The box with envelopes will be safeguarded by the principal investigator using a simple randomization method generated by envelopes from an Excel-generated number table distributed in sets of 8 until reaching the total of 112 patients
Patients randomized to the exercise routine group will be instructed upon recovery about the exercise routine The routine consists of lifting the shoulders as high as possible towards the ears holding for 3 seconds and then resting This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward The routine will be suspended during the night The procedure will be standardized as the principal investigator will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients Telephone and in-person reminders will be made and pain in the shoulders incisions and perineum will be recorded upon leaving the recovery room at 6 hours and 24 hours postoperatively as well as during the follow-up consultations on day 7 and day 30 post-surgery
A data recording sheet with a visual analog scale from 0 to 10 representing the pain graphically will be used to document pain levels upon leaving recovery at 6 and 24 hours postoperatively along with the time and dosage of analgesics and any rescue analgesics used Additionally patient adherence to the exercise routine will be recorded allowing them to document their hospitalization days and the hours of the day when they perform the exercises
Population Patients postoperatively following uncomplicated total laparoscopic hysterectomy for benign conditions in the Department of Gynecology at INPer National Institute of Perinatology
Sample Type Random consecutive cases generated using a random number table in Excel
Sample Size Calculated using a formula for the difference in means of independent samples considering a reported Visual Analog Scale VAS taing into account an VAS score reported at 6 hours postoperative witha mean in the experimental group of 30 SD -20 and the control group of 45 SD 20 with a two tailed hypothesis and statistical power 80 and an alphe error of 005 the sudy requiered a sample size of 28 per group plus 15 of possible dropout rate the result is 33 patients per group and 66 in the total sample
Sampling Type Random consecutive cases
Definition of Units of Observation Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer
Definition of Control Group Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer randomized to the control group which will perform a series of hand exercises
Inclusion Criteria
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology
Mixed anesthesia
Placement of shoulder pads on the surgical table during surgery
Adults who agree to participate and sign informed consent
Exclusion Criteria
Patients with preoperative shoulder pain
Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery
Patients who received a postoperative analgesia pump
Patients participating in another protocol
Elimination Criteria
- Patients with postoperative complications requiring reoperation or Intensive Care Unit admission
x Dependent Variable
Shoulder pain referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders
Exercise Routine
Two groups will be formed for the exercise routine
1 Shoulder Exercises
Operational Definition
- Lift the shoulders as high as possible toward the ears
- Maintain this position for 3 seconds
- Rest
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward
Suspend during the night
2 Hand Exercises
Operational Definition
Open and close the hands making a fist and applying force
Maintain this position for 3 seconds
Rest
Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward
Suspend during the night
Control Variables
1 Visceral Pain Control
Operational Definition
- Visceral pain not at the surgical incision site referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel
2 Incisional Pain Control
Operational Definition
Pain at the surgical incision site referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel
Control Variables
1 Duration of Neumoperitoneum
Operational Definition
- Time in minutes of the duration of CO2 insufflation during the surgical event
2 Average Neumoperitoneum Pressure
Operational Definition
- Average pressure in millimeters of mercury mm Hg of CO2 used during the surgical procedure
3 Use of Intravenous Analgesics in Immediate Postoperative Period
Operational Definition
- Use of intravenous analgesics in the immediate postoperative period This variable includes specific analgesics administered and their administration schedule
4 Rescue Analgesic in Postoperative Period
Operational Definition
- Use of an additional intravenous analgesic for uncontrolled pain in the immediate postoperative period
5 Surgical Drainage
Operational Definition
Placement of any type of negative pressure drainage in the abdominal cavity
6 Age
Operational Definition
The age of the patient in years
7 Body Mass Index BMI
Operational Definition
BMI is a measure of the association between a persons weight and height calculated as weight in kilograms divided by height in square meters
Control Variables Continued
12 Comorbidities
Operational Definition
- Existence of a chronic disease in the patient at the time of surgery This variable includes specific chronic diseases such as hypertension diabetes kidney disease cardiovascular disease psychiatric conditions lung disease immunosuppression chronic pain syndrome and other chronic diseases
13 Chronic Pain Syndrome
Operational Definition
- Presence of chronic pain that can range from mild to severe and persists or evolves for a long period of time 3 months or more
14 Treatment with Psychotropic Drugs
Operational Definition
- Use of medications for the treatment of mental illnesses or alterations of the psychic sphere
15 Depression
Operational Definition
- Assessed using a self-administered questionnaire with 14 items divided into two subscales of seven items each one for anxiety odd-numbered items and one for depression even-numbered items Responses are scored on a Likert scale ranging from 0 to 3 resulting in a minimum score of 0 and a maximum score of 21 for each subscale Based on the scale it is determined if the person has symptoms of anxiety or depression to what extent and whether it constitutes a clinical diagnosis The scale is validated in Mexico
16 Anxiety
Operational Definition
- Assessed using the same questionnaire as for depression 15 with a Likert scale ranging from 0 to 3 The presence and level of anxiety symptoms are determined based on the scores
17 Surgeon
Operational Definition
- The gynecologist trained in gynecological endoscopic surgery who performs the total laparoscopic hysterectomy at the National Institute of Perinatology The study includes various surgeons who perform these procedures
18 Bleeding
Operational Definition
- Blood loss during the surgical procedure measured in milliliters mL
19 Adherence to Exercises
Operational Definition
- Adherence to the exercise routine measured as a percentage of exercises completed during the hospitalization
T A Independent Variable Exercise Routine Two Groups will be Formed
1 Shoulder Exercises Operational Definition Lift the shoulders as high as possible towards the ears hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor Suspend during the night
2 Hand Exercises Operational Definition Open and close the hands while making a fist hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor
B Dependent Variable Shoulder Pain Reported by the Patient on a Visual Analog Scale VAS from 0 to 10 at 6 hours 24 hours and 7 days post-surgery
Type of Variable Quantitative Continuous
Measurement Level 0-10
C Control Variables Bleeding Surgeon Anxiety Depression Treatment with Psychotropic Drugs Chronic Pain Syndrome Comorbidities Body Mass Index Age Surgical Drainage Rescue Analgesic Use Standard Analgesic Regimen CO2 Insufflation Pressure Duration of Pneumoperitoneum
A Independent Variable Exercise Routine Two Groups will be Formed
1 Shoulder Exercises Operational Definition Lift the shoulders as high as possible towards the ears hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor Suspend during the night
2 Hand Exercises Operational Definition Open and close the hands while making a fist hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor
B Dependent Variable Shoulder Pain Reported by the Patient on a Visual Analog Scale VAS from 0 to 10 at 6 hours 24 hours and 7 days post-surgery
Type of Variable Quantitative Continuous
Measurement Level 0-10
C Control Variables Bleeding Surgeon Anxiety Depression Treatment with Psychotropic Drugs Chronic Pain Syndrome Comorbidities Body Mass Index Age Surgical Drainage Rescue Analgesic Use Standard Analgesic Regimen CO2 Insufflation Pressure Duration of Pneumoperitoneum
To evaluate the effect of a shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy at the National Institute of Perinatology
Specific Objectives
1 Describe the frequency and intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy
2 Determine the effect of the shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy
3 Evaluate the adjusted effect of the proposed intervention on pain after identifying potential confounding variables Postoperative management will be similar in both intervention groups so we do not expect to make adjustments In the event that confounding variables are identified we will address them accordingly
Hypothesis
H0 Null Hypothesis Shoulder exercises in the postoperative period do not reduce shoulder pain by at least one point on the Visual Analog Scale compared to a hand exercise routine
Description of the Procedure
Only patients scheduled for surgery at 800 AM will be considered to ensure that the exercise routine has a consistent duration for all patients during the postoperative period Inclusion criteria involve patients receiving mixed anesthesia and all patients will be positioned on the surgical table with shoulder pads and a hip angulation of 15 degrees with inflatable leg supports Patients with negative pressure drains will be excluded from the study The principal investigator will be blinded to the randomization group and patient assessments will be conducted by another investigator
Once a patient agrees to participate in the project and signs the informed consent authorization they will be randomized into one of the treatment groups Randomization will be done using opaque sealed envelopes contained in a box Each envelope will specify the assigned intervention group An equal number of envelopes for both intervention groups will be prepared in advance and shuffled Patients will choose an envelope The box with envelopes will be safeguarded by the principal investigator using a simple randomization method generated by envelopes from an Excel-generated number table distributed in sets of 8 until reaching the total of 112 patients
Patients randomized to the exercise routine group will be instructed upon recovery about the exercise routine The routine consists of lifting the shoulders as high as possible towards the ears holding for 3 seconds and then resting This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward The routine will be suspended during the night The procedure will be standardized as the principal investigator will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients Telephone and in-person reminders will be made and pain in the shoulders incisions and perineum will be recorded upon leaving the recovery room at 6 hours and 24 hours postoperatively as well as during the follow-up consultations on day 7 and day 30 post-surgery
A data recording sheet with a visual analog scale from 0 to 10 representing the pain graphically will be used to document pain levels upon leaving recovery at 6 and 24 hours postoperatively along with the time and dosage of analgesics and any rescue analgesics used Additionally patient adherence to the exercise routine will be recorded allowing them to document their hospitalization days and the hours of the day when they perform the exercises
Population Patients postoperatively following uncomplicated total laparoscopic hysterectomy for benign conditions in the Department of Gynecology at INPer National Institute of Perinatology
Sample Type Random consecutive cases generated using a random number table in Excel
Sample Size Calculated using a formula for the difference in means of independent samples considering a reported Visual Analog Scale VAS taing into account an VAS score reported at 6 hours postoperative witha mean in the experimental group of 30 SD -20 and the control group of 45 SD 20 with a two tailed hypothesis and statistical power 80 and an alphe error of 005 the sudy requiered a sample size of 28 per group plus 15 of possible dropout rate the result is 33 patients per group and 66 in the total sample
Sampling Type Random consecutive cases
Definition of Units of Observation Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer
Definition of Control Group Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer randomized to the control group which will perform a series of hand exercises
Inclusion Criteria
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology
Mixed anesthesia
Placement of shoulder pads on the surgical table during surgery
Adults who agree to participate and sign informed consent
Exclusion Criteria
Patients with preoperative shoulder pain
Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery
Patients who received a postoperative analgesia pump
Patients participating in another protocol
Elimination Criteria
- Patients with postoperative complications requiring reoperation or Intensive Care Unit admission
x Dependent Variable
Shoulder pain referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders
Exercise Routine
Two groups will be formed for the exercise routine
1 Shoulder Exercises
Operational Definition
- Lift the shoulders as high as possible toward the ears
- Maintain this position for 3 seconds
- Rest
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward
Suspend during the night
2 Hand Exercises
Operational Definition
Open and close the hands making a fist and applying force
Maintain this position for 3 seconds
Rest
Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward
Suspend during the night
Control Variables
1 Visceral Pain Control
Operational Definition
- Visceral pain not at the surgical incision site referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel
2 Incisional Pain Control
Operational Definition
Pain at the surgical incision site referred by the patient on a Visual Analog Scale VAS ranging from 0 to 10 at 6 hours 24 hours and 7 days postoperatively The VAS is a tool used to help a person assess the intensity of certain sensations and feelings such as pain It consists of a straight line where one end represents the absence of pain and the other end represents the worst imaginable pain The patient marks a point on the line that corresponds to the amount of pain they feel
Control Variables
1 Duration of Neumoperitoneum
Operational Definition
- Time in minutes of the duration of CO2 insufflation during the surgical event
2 Average Neumoperitoneum Pressure
Operational Definition
- Average pressure in millimeters of mercury mm Hg of CO2 used during the surgical procedure
3 Use of Intravenous Analgesics in Immediate Postoperative Period
Operational Definition
- Use of intravenous analgesics in the immediate postoperative period This variable includes specific analgesics administered and their administration schedule
4 Rescue Analgesic in Postoperative Period
Operational Definition
- Use of an additional intravenous analgesic for uncontrolled pain in the immediate postoperative period
5 Surgical Drainage
Operational Definition
Placement of any type of negative pressure drainage in the abdominal cavity
6 Age
Operational Definition
The age of the patient in years
7 Body Mass Index BMI
Operational Definition
BMI is a measure of the association between a persons weight and height calculated as weight in kilograms divided by height in square meters
Control Variables Continued
12 Comorbidities
Operational Definition
- Existence of a chronic disease in the patient at the time of surgery This variable includes specific chronic diseases such as hypertension diabetes kidney disease cardiovascular disease psychiatric conditions lung disease immunosuppression chronic pain syndrome and other chronic diseases
13 Chronic Pain Syndrome
Operational Definition
- Presence of chronic pain that can range from mild to severe and persists or evolves for a long period of time 3 months or more
14 Treatment with Psychotropic Drugs
Operational Definition
- Use of medications for the treatment of mental illnesses or alterations of the psychic sphere
15 Depression
Operational Definition
- Assessed using a self-administered questionnaire with 14 items divided into two subscales of seven items each one for anxiety odd-numbered items and one for depression even-numbered items Responses are scored on a Likert scale ranging from 0 to 3 resulting in a minimum score of 0 and a maximum score of 21 for each subscale Based on the scale it is determined if the person has symptoms of anxiety or depression to what extent and whether it constitutes a clinical diagnosis The scale is validated in Mexico
16 Anxiety
Operational Definition
- Assessed using the same questionnaire as for depression 15 with a Likert scale ranging from 0 to 3 The presence and level of anxiety symptoms are determined based on the scores
17 Surgeon
Operational Definition
- The gynecologist trained in gynecological endoscopic surgery who performs the total laparoscopic hysterectomy at the National Institute of Perinatology The study includes various surgeons who perform these procedures
18 Bleeding
Operational Definition
- Blood loss during the surgical procedure measured in milliliters mL
19 Adherence to Exercises
Operational Definition
- Adherence to the exercise routine measured as a percentage of exercises completed during the hospitalization
T A Independent Variable Exercise Routine Two Groups will be Formed
1 Shoulder Exercises Operational Definition Lift the shoulders as high as possible towards the ears hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor Suspend during the night
2 Hand Exercises Operational Definition Open and close the hands while making a fist hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor
B Dependent Variable Shoulder Pain Reported by the Patient on a Visual Analog Scale VAS from 0 to 10 at 6 hours 24 hours and 7 days post-surgery
Type of Variable Quantitative Continuous
Measurement Level 0-10
C Control Variables Bleeding Surgeon Anxiety Depression Treatment with Psychotropic Drugs Chronic Pain Syndrome Comorbidities Body Mass Index Age Surgical Drainage Rescue Analgesic Use Standard Analgesic Regimen CO2 Insufflation Pressure Duration of Pneumoperitoneum
A Independent Variable Exercise Routine Two Groups will be Formed
1 Shoulder Exercises Operational Definition Lift the shoulders as high as possible towards the ears hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor Suspend during the night
2 Hand Exercises Operational Definition Open and close the hands while making a fist hold for 3 seconds and rest Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor
B Dependent Variable Shoulder Pain Reported by the Patient on a Visual Analog Scale VAS from 0 to 10 at 6 hours 24 hours and 7 days post-surgery
Type of Variable Quantitative Continuous
Measurement Level 0-10
C Control Variables Bleeding Surgeon Anxiety Depression Treatment with Psychotropic Drugs Chronic Pain Syndrome Comorbidities Body Mass Index Age Surgical Drainage Rescue Analgesic Use Standard Analgesic Regimen CO2 Insufflation Pressure Duration of Pneumoperitoneum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None