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

Usama Ahmed Elsaeed Salem, MD

Status: Completed

Conditions: Recovery Outcomes; Postoperative Pain; Pain Management; Gynecologic Laparoscopic Surgery

Treatments: Drug: Bupivacaine 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT07030647

MS-447-2024

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Port Site Local Anesthetic Injection (Group A)

Experimental group

Description:

Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery.

Treatment:

Drug: Bupivacaine 0.25%

Drug: Bupivacaine 0.25%

Intraperitoneal Local Anesthetic Injection (Group B)

Experimental group

Description:

Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments.

Treatment:

Drug: Bupivacaine 0.25%

Drug: Bupivacaine 0.25%

Control (Group C)

No Intervention group

Description:

Participants receive no local anesthetic injection during surgery.