Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

NCT ID: NCT05214157

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-01-08

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.

Conditions

Acute Post-operative Pain; Cholecystectomy, Laparoscopic; Pain Assessment Pain Intensity; Pain Intensity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

group A

interventional group, final two operative steps applied

Group Type: EXPERIMENTAL

active gas aspiration

Intervention Type: PROCEDURE

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

group B

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

active gas aspiration

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

Intervention Type: PROCEDURE

Other Intervention Names

application of Bupivacaine soaked sponge

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed lotfy

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed l ali, md

Role: STUDY_DIRECTOR

Zagazig University

Locations

Zagazig University

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

zuh 243

Identifier Type: -

Identifier Source: org_study_id