Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

Cholecystectomy, Laparoscopic Clinical Trial

— Pain  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214157
• Other study ID #: zuh 243
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: January 8, 2022

Study information

• Verified date: January 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: January 8, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Post-operative Pain
• Cholecystectomy, Laparoscopic
• Pain
• Pain Intensity
• Pain, Postoperative

Intervention

Procedure:
• active gas aspiration
sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain intensity	severity by visual analogue scale	6 - 24 hours
Secondary	hospital stay	numbers of days	1-5 days