Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03241602
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-08-03
Brief Title:
Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain in Patient Undergoing Diagnostic Gynacological Laproscopy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-01
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:
None
Brief Summary:
The advancement of laparoscopy and minimal access surgery has greatly influenced the evolution of anaesthetic techniques However postoperative pain intensity may be significant with up to 40 of patients unsatisfied by routine analgesia and up to 80may require rescue opioids during their hospital stay Diagnostic gynaecological laparoscopy has no origin of pain other than the abdominal gas insufflations itself only Pain relief after diagnostic laparoscopy being a day case is an issue of great practical importanceThe aim of this study is to compare the efficacy of combining both pulmonary recruitment and intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy shoulder pain regarding severity and frequency
Study Design
Interventional Prospective Randomized Double-blind Controlled Trial
Methodology This study is a randomized double blinded control trial It will be conducted at Kasr-al ainy hospital faculty of medicine Cairo university Approval of ethical committee and written informed consent will be obtained 88 female patients aged 18-45 years ASA 1 or 2 scheduled for diagnostic gynaecologic laparoscopy will be included Females who are ASA 3 alcoholic drug abusers allergic to amide LAs with pre-existing chronic pain disorders or receiving opioids or tranquilizers for 1 week preoperatively are excluded Also if the operation included any interventional procedure or was converted to an open procedure or had postoperative complications that could increase postoperative pain it will be excluded Consenting patients will be randomly allocated to either of three study groups GPL Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine GPS Patients will receive pulmonary recruitment maneuver and intraperitoneal saline GC Patients will receive passive exsufflation through the port site The patient will attend at the pre anaesthetic room 1 hour before the procedure A 20 Gauge cannula will be inserted peripherally and the patient will be premedicated with intravenous Midazolam 002 mg kg-1 Ranitidine 50 mg 10 mg Metoclopramide
In the operative room standard monitoring will be applied to the patient Anaesthesia will be induced with propofol 2 mg kg-1 Fentanyl 1 mcg kg-1 Atracurium 05 mg kg-1 and the trachea will be intubated after mask ventilation for 3 minutes Anaesthesia will be maintained with IPPV isoflurane in 100 oxygen and muscular relaxation with atracurium 01mg kg-1every 15 minutes Depth of anaesthesia was adjusted according to clinical signs Laparoscopy is done using CO2 as distension medium The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view In groups GPL and GPS the investigator prepares syringes 175 mlkg of 02 lidocaine 35 mgkg or the same volume of normal saline for intraperitoneal administration This ensures the surgeon and the anaesthesiologist are blind to the patients group The solution to be instilled will be splashed under the right diaphragmatic area by the surgeon and complete the procedure At the end of the procedure the patient will be placed back from trendelenburg position In groups GPL and GPS a pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O The anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds In group GC CO2 will be removed by passive exsufflation through the port site and gentle abdominal pressure will be applied to evacuate the residual gas Residual neuromuscular block is antagonized with atropine 12 mg and neostigmine 25 mg and extubation will be done according to extubation criteria In the recovery room patient will be asked about post-operative pain and itll be controlled using Meperidine 1 mg kg-1 and given by a nurse who is unaware of the nature of the intraoperative analgesia Then the patient is discharged to the ward according to the standard criteria In the ward patient will be asked to fulfill a questionnaire at 6 8 and 10 hours postoperative using the visual analogue score VAS of pain severity Patients were questioned as to presence of Side effects nausea vomiting
Possible Risk Pneumothorax Local anaesthetic toxicity CNS depression lightheadedness and dizziness difficulty focusing tinnitus confusion and circumoral numbness excitation tremors tonic-clonic convulsions respiratory depression and cardiac dysrhythmias
Study Design
Interventional Prospective Randomized Double-blind Controlled Trial
Methodology This study is a randomized double blinded control trial It will be conducted at Kasr-al ainy hospital faculty of medicine Cairo university Approval of ethical committee and written informed consent will be obtained 88 female patients aged 18-45 years ASA 1 or 2 scheduled for diagnostic gynaecologic laparoscopy will be included Females who are ASA 3 alcoholic drug abusers allergic to amide LAs with pre-existing chronic pain disorders or receiving opioids or tranquilizers for 1 week preoperatively are excluded Also if the operation included any interventional procedure or was converted to an open procedure or had postoperative complications that could increase postoperative pain it will be excluded Consenting patients will be randomly allocated to either of three study groups GPL Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine GPS Patients will receive pulmonary recruitment maneuver and intraperitoneal saline GC Patients will receive passive exsufflation through the port site The patient will attend at the pre anaesthetic room 1 hour before the procedure A 20 Gauge cannula will be inserted peripherally and the patient will be premedicated with intravenous Midazolam 002 mg kg-1 Ranitidine 50 mg 10 mg Metoclopramide
In the operative room standard monitoring will be applied to the patient Anaesthesia will be induced with propofol 2 mg kg-1 Fentanyl 1 mcg kg-1 Atracurium 05 mg kg-1 and the trachea will be intubated after mask ventilation for 3 minutes Anaesthesia will be maintained with IPPV isoflurane in 100 oxygen and muscular relaxation with atracurium 01mg kg-1every 15 minutes Depth of anaesthesia was adjusted according to clinical signs Laparoscopy is done using CO2 as distension medium The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view In groups GPL and GPS the investigator prepares syringes 175 mlkg of 02 lidocaine 35 mgkg or the same volume of normal saline for intraperitoneal administration This ensures the surgeon and the anaesthesiologist are blind to the patients group The solution to be instilled will be splashed under the right diaphragmatic area by the surgeon and complete the procedure At the end of the procedure the patient will be placed back from trendelenburg position In groups GPL and GPS a pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O The anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds In group GC CO2 will be removed by passive exsufflation through the port site and gentle abdominal pressure will be applied to evacuate the residual gas Residual neuromuscular block is antagonized with atropine 12 mg and neostigmine 25 mg and extubation will be done according to extubation criteria In the recovery room patient will be asked about post-operative pain and itll be controlled using Meperidine 1 mg kg-1 and given by a nurse who is unaware of the nature of the intraoperative analgesia Then the patient is discharged to the ward according to the standard criteria In the ward patient will be asked to fulfill a questionnaire at 6 8 and 10 hours postoperative using the visual analogue score VAS of pain severity Patients were questioned as to presence of Side effects nausea vomiting
Possible Risk Pneumothorax Local anaesthetic toxicity CNS depression lightheadedness and dizziness difficulty focusing tinnitus confusion and circumoral numbness excitation tremors tonic-clonic convulsions respiratory depression and cardiac dysrhythmias
Detailed Description:
The advancement of laparoscopy and minimal access surgery has greatly influenced the evolution of anaesthetic techniques However postoperative pain intensity may be significant with up to 40 of patients unsatisfied by routine analgesia and up to 80may require rescue opioids during their hospital stay Diagnostic gynaecological laparoscopy has no origin of pain other than the abdominal gas insufflations itself only Pain relief after diagnostic laparoscopy being a day case is an issue of great practical importance Pain after Laparoscopy is considered to arise from 3 main sources the incision sites 50 to 70 the pneumoperitoneum 20 to 30 in association with both local peritoneal and diaphragmatic stretching ischemia acidosis and systemic hypercarbia causing sympathetic nervous system excitation resulting in amplification of the local tissue inflammatory response changes and the procedure site 10 to 20 as postcholecystectomy wound within the liver Pain can also be referred from the subdiaphragmatic region as shoulder pain Shoulder pain is often mild in intensity and can remain for 24 hours Incisional pain is usually mild to moderate in intensity and maximal immediately postoperatively subsiding with time Local anaesthetic LA to be filtered preincisional can not entirely eliminate postoperative pain especially shoulder pain In contrast Intraperitoneal local anaesthetic instillation is a known method of providing post-laparoscopy pain relief Lidocaine is safe and effective in pain relief improving respiratory functions and early return of bowel motility The local anaesthetic blocks visceral nociception from the peritoneum locally as well as a having a systemic effect after absorption through the peritoneal surface The systemic analgesic effect of LA is induced through an anti-inflammatory effect by peripheral suppression of acute chemically induced pain inhibition of nerve conduction as well as having a central antihyperalgesic effect The pulmonary recruitment manoeuvre RM can mechanically remove residual carbon dioxide CO2 after laparoscopic surgery reduce phrenic nerve irritation and consequently reduce post-laparoscopic shoulder and upper abdominal pain The combined effect of these two methods using various local anaesthetics on pain following laparoscopic procedures has not been reported This study will investigate the efficacy of combining local anaesthetic infiltration of Lidocaine with pulmonary recruitment manoeuvre on postoperative pain following diagnostic Gynaecologic laparoscopy For blinding Pulmonary recruitment maneuver will be combined with intraperitoneal instillation of saline However intraperitoneal saline is a known simple maneuver to decrease shoulder pain A possible explanation is that saline displaces residual pockets of gas from within the peritoneal cavity and thereby prevents loss of suction support between the liver and diaphragm In this study we hypothesized that combining simple maneuver like pulmonary recruitment with intraperitoneal instillation of local anaesthetic would be more effective than pulmonary recruitment alone
The aim of this study is to compare the efficacy of combining both pulmonary recruitment and intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy shoulder pain regarding severity and frequency
Study Design
Interventional Prospective Randomized Double-blind Controlled Trial
Study Methods
Methodology This study is a randomized double blinded control trial It will be conducted at Kasr-al ainy hospital faculty of medicine Cairo university Approval of ethical committee and written informed consent will be obtained 88 female patients aged 18-45 years ASA I or II scheduled for diagnostic gynaecologic laparoscopy will be included Females who are ASA 3 alcoholic drug abusers allergic to amide LAs with pre-existing chronic pain disorders or receiving opioids or tranquilizers for 1 week preoperatively are excluded Also if the operation included any interventional procedure or was converted to an open procedure or had postoperative complications that could increase postoperative pain it will be excluded Consenting patients will be randomly allocated to either of three study groups GPL Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine GPS Patients will receive pulmonary recruitment maneuver and intraperitoneal saline GC Patients will receive passive exsufflation through the port site The patient will attend at the pre anaesthetic room 1 hour before the procedure A 20 Gauge cannula will be inserted peripherally and the patient will be premedicated with intravenous Midazolam 002 mg kg-1 Ranitidine 50 mg 10 mg Metoclopramide
In the operative room standard monitoring electrocardiography pulse oximetry and non-invasive blood pressure measurement will be applied to the patient
Anaesthesia will be induced with propofol 2 mg kg Fentanyl 1 mcg kg Atracurium 05 mg kg-1 and the trachea will be intubated after mask ventilation for 3 minutes Anaesthesia will be maintained with IPPV isoflurane in 100 oxygen and muscular relaxation with atracurium 01mg kg-1every 15 minutes Depth of anaesthesia was adjusted according to clinical signs Laparoscopy is done using CO2 as distension medium Veress needle is introduced at first through lower border of umbilicus and water test is done to ensure intraperitoneal placement Then reaching proper distension pressure is ensured by disappearance of dullness over lower border of the liver The pressure will be about 15 mmHg The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view A 10 mm laparoscopic trocar is introduced with 45 degree towards pelvis and zero camera is introduced through the cannula trocar Second puncture can be done through right or left iliac fossae In groups GPL and GPS the investigator prepares syringes 175 mlkg of 02 lidocaine 35 mgkg or the same volume of normal saline for intraperitoneal administration This ensures the surgeon and the anaesthesiologist are blind to the patients group The solution to be instilled will be splashed under the right diaphragmatic area by the surgeon and complete the procedure At the end of the procedure the patient will be placed back from trendelenburg position In groups GPL and GPS a pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O The anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds In group GC CO2 will be removed by passive exsufflation through the port site and gentle abdominal pressure will be applied to evacuate the residual gas Residual neuromuscular block is antagonized with atropine 12 mg and neostigmine 25 mg and extubation will be done according to extubation criteria In the recovery room patient will be asked about post-operative pain and itll be controlled using Meperidine 1 mg kg and given by a nurse who is unaware of the nature of the intraoperative analgesia Then the patient is discharged to the ward according to the standard criteria In the ward patient will be asked to fulfill a questionnaire at 6 8 and 10 hours postoperative using the visual analogue score VAS of pain severity The patients were asked to complete a 10-cm linear analogue scale for shoulder pain which ranged from 0 for no pain at all to 10 for the worst pain imaginable Patients were questioned as to presence of Side effects nausea vomiting
Possible Risk Pneumothorax Local anaesthetic toxicity CNS depression lightheadedness and dizziness difficulty focusing tinnitus confusion and circumoral numbness excitation tremors tonic-clonic convulsions respiratory depression and cardiac dysrhythmias
The aim of this study is to compare the efficacy of combining both pulmonary recruitment and intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy shoulder pain regarding severity and frequency
Study Design
Interventional Prospective Randomized Double-blind Controlled Trial
Study Methods
Methodology This study is a randomized double blinded control trial It will be conducted at Kasr-al ainy hospital faculty of medicine Cairo university Approval of ethical committee and written informed consent will be obtained 88 female patients aged 18-45 years ASA I or II scheduled for diagnostic gynaecologic laparoscopy will be included Females who are ASA 3 alcoholic drug abusers allergic to amide LAs with pre-existing chronic pain disorders or receiving opioids or tranquilizers for 1 week preoperatively are excluded Also if the operation included any interventional procedure or was converted to an open procedure or had postoperative complications that could increase postoperative pain it will be excluded Consenting patients will be randomly allocated to either of three study groups GPL Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine GPS Patients will receive pulmonary recruitment maneuver and intraperitoneal saline GC Patients will receive passive exsufflation through the port site The patient will attend at the pre anaesthetic room 1 hour before the procedure A 20 Gauge cannula will be inserted peripherally and the patient will be premedicated with intravenous Midazolam 002 mg kg-1 Ranitidine 50 mg 10 mg Metoclopramide
In the operative room standard monitoring electrocardiography pulse oximetry and non-invasive blood pressure measurement will be applied to the patient
Anaesthesia will be induced with propofol 2 mg kg Fentanyl 1 mcg kg Atracurium 05 mg kg-1 and the trachea will be intubated after mask ventilation for 3 minutes Anaesthesia will be maintained with IPPV isoflurane in 100 oxygen and muscular relaxation with atracurium 01mg kg-1every 15 minutes Depth of anaesthesia was adjusted according to clinical signs Laparoscopy is done using CO2 as distension medium Veress needle is introduced at first through lower border of umbilicus and water test is done to ensure intraperitoneal placement Then reaching proper distension pressure is ensured by disappearance of dullness over lower border of the liver The pressure will be about 15 mmHg The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view A 10 mm laparoscopic trocar is introduced with 45 degree towards pelvis and zero camera is introduced through the cannula trocar Second puncture can be done through right or left iliac fossae In groups GPL and GPS the investigator prepares syringes 175 mlkg of 02 lidocaine 35 mgkg or the same volume of normal saline for intraperitoneal administration This ensures the surgeon and the anaesthesiologist are blind to the patients group The solution to be instilled will be splashed under the right diaphragmatic area by the surgeon and complete the procedure At the end of the procedure the patient will be placed back from trendelenburg position In groups GPL and GPS a pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O The anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds In group GC CO2 will be removed by passive exsufflation through the port site and gentle abdominal pressure will be applied to evacuate the residual gas Residual neuromuscular block is antagonized with atropine 12 mg and neostigmine 25 mg and extubation will be done according to extubation criteria In the recovery room patient will be asked about post-operative pain and itll be controlled using Meperidine 1 mg kg and given by a nurse who is unaware of the nature of the intraoperative analgesia Then the patient is discharged to the ward according to the standard criteria In the ward patient will be asked to fulfill a questionnaire at 6 8 and 10 hours postoperative using the visual analogue score VAS of pain severity The patients were asked to complete a 10-cm linear analogue scale for shoulder pain which ranged from 0 for no pain at all to 10 for the worst pain imaginable Patients were questioned as to presence of Side effects nausea vomiting
Possible Risk Pneumothorax Local anaesthetic toxicity CNS depression lightheadedness and dizziness difficulty focusing tinnitus confusion and circumoral numbness excitation tremors tonic-clonic convulsions respiratory depression and cardiac dysrhythmias
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