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OpenTrials
Completed

NCT Number: NCT05214157

Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Egypt

About this study

Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who were having symptoms consistent with biliary colic,
  • had ultrasound evidence of gall stones,
  • classified as American Society of Anesthesiology (ASA) I and II
  • ages ranging from 18 to 65 years

Exclusion criteria

  • Patients who refused to give consent,
  • pregnant,
  • had a history of drug abuse,
  • had CBD stones,
  • acute cholecystitis,
  • acute pancreatitis,
  • previous abdominal surgery,
  • history of peritonitis,
  • had carcinoma of the gall bladder Patients who were converted to open surgery,
  • patients who required placement of drains
  • patients with intraoperative complications (CBD injury or liver bed bleeding).

Treatment and study plan

active gas aspiration

Procedure

sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites

Other names: application of Bupivacaine soaked sponge

Primary outcomes

  1. postoperative pain intensity

    Time frame: 6 - 24 hours

    severity by visual analogue scale

Secondary outcomes

  1. hospital stay

    Time frame: 1-5 days

    numbers of days

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy

Acronym: Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jan 28, 2022

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.

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