Gall Bladder Bed Infiltration Analgesia

NCT ID: NCT03693820

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2019-07-11

Brief Summary

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

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

the infiltration group

Intervention Type: DRUG

• 15-20 ml periportal,
• 50 ml in gallbladder bed,
• The rest (about 150 ml in 70 Kg patient) will be intraperitoneal

the control group

the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.

Group Type: PLACEBO_COMPARATOR

the control group

Intervention Type: DRUG

the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

Interventions

the infiltration group

• 15-20 ml periportal,
• 50 ml in gallbladder bed,
• The rest (about 150 ml in 70 Kg patient) will be intraperitoneal

Intervention Type: DRUG

the control group

the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alaa Mazy Mazy

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy Mazy

associate prosseor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

alaa mazy, MD

Role: STUDY_DIRECTOR

faculty of medicine, Mansoura

Locations

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, Egypt

Countries

Egypt

Other Identifiers

MS.18.09.277

Identifier Type: -

Identifier Source: org_study_id