Skip to main content
OpenTrials
Completed

NCT Number: NCT03693820

Gall Bladder Bed Infiltration Analgesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the infiltration group

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

Drug

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

Primary outcomes

  1. The total postoperative analgesic consumption

    Time frame: postoperative, for 24 hours

    ketorolac and morphine in mg .

Secondary outcomes

  1. The time to the first request of analgesia

    Time frame: postoperative, for 24 hours

    hours

  2. The intraoperative fentanyl requirements.

    Time frame: intraoperative

    microgram

  3. postoperative pain score: VAS

    Time frame: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours

    visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,

  4. heart rate

    Time frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.

    beat/ minute

  5. mean blood pressure

    Time frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.

    mmHg

  6. incidence of vomiting

    Time frame: postoperatively, during the first 24 hours

    number

  7. the sleep quality

    Time frame: postoperatively, after the first night.

    through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.

  8. Patient satisfaction regards analgesia:

    Time frame: postoperative after 24 hour.

    using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.

  9. Surgeon satisfaction regards the technique:

    Time frame: postoperative within 1 hour.

    using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.

Sponsors and collaborators

Lead sponsor

Alaa Mazy Mazy

Other

Registry information

Official study title

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.