Gall Bladder Bed Infiltration Analgesia

Study Overview
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Brief Summary
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Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.

Detailed Description
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Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes. In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.

Official Title
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The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: the infiltration group
* Drug: the control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo elective laparoscopic cholecystectomy. American Society of Anesthesiologists physical status (ASA) I or II. Exclusion Criteria: Patient in receipt of analgesics or sedatives 24 h before scheduled surgery. Patient with spillage or cholelithiasis with known common bile duct pathology. Body Mass Index > 40 Kg/m2. Patient underlying severe systemic disease. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the infiltration group<br>a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China). | Drug: the infiltration group<br>* 15-20 ml periportal, 50 ml in gallbladder bed, The rest (about 150 ml in 70 Kg patient) will be intraperitoneal<br>|
| Placebo Comparator: the control group<br>the same technique but the 50 ml for gallbladder infiltration will be replaced by saline. | Drug: the control group<br>* the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total postoperative analgesic consumption | ketorolac and morphine in mg . | postoperative, for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the first request of analgesia | hours | postoperative, for 24 hours | 
| The intraoperative fentanyl requirements. | microgram | intraoperative | 
| postoperative pain score: VAS | visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain, | postoperative at 0, 2, 4, 8, 12, 16 and 24 hours | 
| heart rate | beat/ minute | basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. | 
| mean blood pressure | mmHg | basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. | 
| incidence of vomiting | number | postoperatively, during the first 24 hours | 
| the sleep quality | through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep. | postoperatively, after the first night. | 
| Patient satisfaction regards analgesia: | using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction. | postoperative after 24 hour. | 
| Surgeon satisfaction regards the technique: | using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction. | postoperative within 1 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain