Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

Not Applicable

Completed

• Conditions: Acute Post-operative Pain; Cholecystectomy, Laparoscopic; Pain Assessment Pain Intensity; Pain Intensity
• Interventions: Procedure: active gas aspiration

• Registration Number: NCT05214157
• Lead Sponsor: Zagazig University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-20
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-08
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	active gas aspiration	interventional group, final two operative steps applied

Primary Outcome Measures

Name	Time	Method
postoperative pain intensity	6 - 24 hours	severity by visual analogue scale

Secondary Outcome Measures

Name	Time	Method
hospital stay	1-5 days	numbers of days

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt