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Trials / Completed

CompletedNCT03693820

Gall Bladder Bed Infiltration Analgesia

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Alaa Mazy Mazy · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGthe infiltration group* 15-20 ml periportal, * 50 ml in gallbladder bed, * The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
DRUGthe control groupthe 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

Timeline

Start date
2018-09-10
Primary completion
2019-06-01
Completion
2019-07-11
First posted
2018-10-03
Last updated
2020-09-18

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03693820. Inclusion in this directory is not an endorsement.