Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595329
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma RCC Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay open surgery is still often performed Open nephrectomy causes significant acute postoperative pain and it can also lead to the development of chronic postoperative pain Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery ERAS program
In this prospective randomized clinical study we plan to compare two different approaches to pain management regarding the level of acute pain first 72 hours side effects systemic analgesics consumption and hospital stay
Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay
In this prospective randomized clinical study we plan to compare two different approaches to pain management regarding the level of acute pain first 72 hours side effects systemic analgesics consumption and hospital stay
Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay
Detailed Description:
This is a prospective single-center randomized controlled trial The study will take place in the University Hospital of Split Departments of Anesthesiology Reanimatology and Intensive Care Medicine and the Department of Urology
Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups Epidural analgesia Control or intrathecal opioid Intervention group Physiologic functions blood pressure heart rate peripheral oxygen saturation will be monitored during and after the surgery Postoperatively pain scores at rest as well as during movement will be recorded A total dose of intraoperative opioids time to first rescue analgesic and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded These parameters will be compared between the two groups
Data sources
Patient records electronic and paper direct measurements of patients physiologic functions perioperatively during first 72 hours postoperatively pain assessment at rest and movement Numerical rating scale NRS
Ways of collection of data
Direct measurements will be used for physiologic functions change in heart rate and blood pressure NRS questionnaire will be used to measure pain at rest and during movement in the first 72 hours Patient records will be used for demographic data and to measure side effects of the received treatment and length of ICU and hospital stay
Measurements will be conducted by anesthesiologists in the operating room staff in the ICU during the period we are investigating 72 hours after the procedure and researchers going through patients records
The population represented by the sample
Patients scheduled for open radical or partial nephrectomy due to RCC
Independent variables
Demographic data age gender weight comorbidities chronic medication chronic pain medication American Society of Anesthesiologists ASA score duration of surgery duration of anesthesia baseline NRS score
Intervention group
Patients with RCC undergoing open nephrectomy randomized into a group receiving intrathecal morphine
Control group
Patients who will receive epidural analgesia will be treated as a control group given that epidural analgesia is the most favorable analgesic technique in accordance with ERAS protocol for major abdominal surgeries
Tehnique of randomisation
Participants will be randomly divided into two groups in a 11 ratio Randomization will be performed using a computer program A research coordinator will be designated to distribute and preserve randomization results
Patients with RCC undergoing open nephrectomy will be asked to sign written informed consent before the enrolment should they choose to participate in this study They will be instructed on how to self-assess pain severity via the numeric rating scale before surgery NRS an 11-point scale where 0 no pain and 10 most severe pain
Treatmentintervention
Patients undergoing open radical or partial nephrectomy will randomly receive either epidural analgesia or intrathecal morphine
Patients in the Intervention group will receive a single dose of 300 mcg of morphine intrathecally before induction to general anesthesia For patients in the control group an epidural catheter will be placed before induction to the anesthesia A local anesthetic levobupivacaine 025 will be administered as a bolus dose during the surgery and continuously 0125 levobupivacaine during the first 24 hours postoperatively After the intervention patients will undergo general anesthesia
Changes in heart rate blood pressure and the total dose of opioids administered are going to be measured intraoperatively After the procedure patients are going to be admitted to the intensive care unit in the Urology department In the first 72 hours we will be measuring pain at rest using the Numerical rating scale NRS pain during cough using NRS time of the first rescue analgesia total dose of additional analgesics during 72 hours postoperatively and the incidence of adverse effects hypotension bradycardia nausea vomiting pruritus respiratory insufficiency We will analyze the quality of recovery and time to gastrointestinal function recovery Complications of intervention will also be noted accidental dural puncture post-dural puncture headache failed block unintentional intravascular injection of local anesthetic and local anesthetic toxicity Length of ICU and hospital stay will also be measured Patients will be exposed to intervention before the surgery epidural catheter will be extracted after 24 hours The expected duration of the study is onetwo years
Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups Epidural analgesia Control or intrathecal opioid Intervention group Physiologic functions blood pressure heart rate peripheral oxygen saturation will be monitored during and after the surgery Postoperatively pain scores at rest as well as during movement will be recorded A total dose of intraoperative opioids time to first rescue analgesic and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded These parameters will be compared between the two groups
Data sources
Patient records electronic and paper direct measurements of patients physiologic functions perioperatively during first 72 hours postoperatively pain assessment at rest and movement Numerical rating scale NRS
Ways of collection of data
Direct measurements will be used for physiologic functions change in heart rate and blood pressure NRS questionnaire will be used to measure pain at rest and during movement in the first 72 hours Patient records will be used for demographic data and to measure side effects of the received treatment and length of ICU and hospital stay
Measurements will be conducted by anesthesiologists in the operating room staff in the ICU during the period we are investigating 72 hours after the procedure and researchers going through patients records
The population represented by the sample
Patients scheduled for open radical or partial nephrectomy due to RCC
Independent variables
Demographic data age gender weight comorbidities chronic medication chronic pain medication American Society of Anesthesiologists ASA score duration of surgery duration of anesthesia baseline NRS score
Intervention group
Patients with RCC undergoing open nephrectomy randomized into a group receiving intrathecal morphine
Control group
Patients who will receive epidural analgesia will be treated as a control group given that epidural analgesia is the most favorable analgesic technique in accordance with ERAS protocol for major abdominal surgeries
Tehnique of randomisation
Participants will be randomly divided into two groups in a 11 ratio Randomization will be performed using a computer program A research coordinator will be designated to distribute and preserve randomization results
Patients with RCC undergoing open nephrectomy will be asked to sign written informed consent before the enrolment should they choose to participate in this study They will be instructed on how to self-assess pain severity via the numeric rating scale before surgery NRS an 11-point scale where 0 no pain and 10 most severe pain
Treatmentintervention
Patients undergoing open radical or partial nephrectomy will randomly receive either epidural analgesia or intrathecal morphine
Patients in the Intervention group will receive a single dose of 300 mcg of morphine intrathecally before induction to general anesthesia For patients in the control group an epidural catheter will be placed before induction to the anesthesia A local anesthetic levobupivacaine 025 will be administered as a bolus dose during the surgery and continuously 0125 levobupivacaine during the first 24 hours postoperatively After the intervention patients will undergo general anesthesia
Changes in heart rate blood pressure and the total dose of opioids administered are going to be measured intraoperatively After the procedure patients are going to be admitted to the intensive care unit in the Urology department In the first 72 hours we will be measuring pain at rest using the Numerical rating scale NRS pain during cough using NRS time of the first rescue analgesia total dose of additional analgesics during 72 hours postoperatively and the incidence of adverse effects hypotension bradycardia nausea vomiting pruritus respiratory insufficiency We will analyze the quality of recovery and time to gastrointestinal function recovery Complications of intervention will also be noted accidental dural puncture post-dural puncture headache failed block unintentional intravascular injection of local anesthetic and local anesthetic toxicity Length of ICU and hospital stay will also be measured Patients will be exposed to intervention before the surgery epidural catheter will be extracted after 24 hours The expected duration of the study is onetwo years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None