Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT

Zagazig University

Status: Completed

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

Treatments: Procedure: active gas aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT05214157

zuh 243

Details and patient eligibility

About

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

Full 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.

Enrollment: 804 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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804 participants in 2 patient groups

group A

Experimental group

Description:

interventional group, final two operative steps applied

Treatment:

Procedure: active gas aspiration

group B

No Intervention group

Description:

control group