"Efficacy of Local Anesthetic for Postoperative Pain in Gynecologic Laparoscopy"

Not Applicable

Completed

• Conditions: Gynecologic Laparoscopic Surgery; Postoperative Pain; Recovery Outcomes; Pain Management
• Interventions: Drug: Bupivacaine 0.25%

• Registration Number: NCT07030647
• Lead Sponsor: Usama Ahmed Elsaeed Salem, MD

Brief Summary

This is a randomized, double-blind, controlled clinical trial evaluating the efficacy of local anesthetic (LA) in reducing postoperative pain in patients undergoing gynecologic laparoscopic surgery. Ninety participants will be randomly assigned into three equal groups: Group A will receive LA injection at the port site, Group B will receive intraperitoneal LA injection, and Group C will serve as the control group with no LA intervention. Postoperative pain will be assessed and compared among the three groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2025-02-05
• Study Completion: 2025-03-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Female participants aged 18 to 60 years

Scheduled for elective gynecological laparoscopic procedures, including:

Evaluation for primary or secondary infertility

Assessment of suspected uterine pathology

Evaluation of Müllerian anomalies

Assessment of suspected tubal or peritoneal pathology requiring diagnostic exploration.

Exclusion Criteria

Known allergy or hypersensitivity to local anesthetics (e.g., lidocaine or bupivacaine)

Body Mass Index (BMI) ≥ 35 kg/m²

Severe hepatic or renal impairment

Chronic pain conditions requiring regular opioid use

History of major abdominal surgery

Refusal to provide informed consent or to enroll in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Port Site Local Anesthetic Injection (Group A)	Bupivacaine 0.25%	Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery.
Intraperitoneal Local Anesthetic Injection (Group B)	Bupivacaine 0.25%	Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain score assessed using the Visual Analog Scale .	24 hours after surgery	Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Time to First Analgesic Request	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Total Analgesic Consumption	within 24 hours after surgery
Patient Satisfaction Score	24 hours postoperatively	Patient satisfaction will be measured using a10- point Likert Scale, where 1 = Very Dissatisfied and 10 = Very Satisfied. Higher scores indicate greater satisfaction.
Length of Hospital Stay	From end of surgery until hospital discharge assessed up to 7 days	The duration (in hours) from the end of surgery to the time of hospital discharge will be recorded. This outcome measures the efficiency of recovery and readiness for discharge.
Time to First Patient Ambulation	Within 24 hours after surgery

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Cairo Governorate, Egypt