Gall Bladder Bed Infiltration Analgesia

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: the infiltration group; Drug: the control group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Dakahleia
    • Mansourah, Al-Dakahleia, Egypt, 35516
      • Gastro-enterolgy surgical center, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo elective laparoscopic cholecystectomy.
• American Society of Anesthesiologists physical status (ASA) I or II.

Exclusion Criteria:

1. Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
2. Patient with spillage or cholelithiasis with known common bile duct pathology.
3. Body Mass Index > 40 Kg/m2.
4. Patient underlying severe systemic disease.
5. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the infiltration group; 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; 15-20 ml periportal,; 50 ml in gallbladder bed,; The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
Placebo Comparator: the control group; the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.	Drug: the control group; the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Alaa Mazy Mazy
• Investigators: Study Director: alaa mazy, MD, faculty of medicine, Mansoura

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: visceral pain; cholecystectomy;; analgesia;; gallbladder;; infiltration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: MS.18.09.277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No