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NCT Number: NCT07030647

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

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.

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Key information

Conditions

Gynecologic Laparoscopic Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Recovery Outcomes Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.25%

Drug

At the end of gynecologic laparoscopic surgery and prior to trocar removal, 40 mL of Bupivacaine 0.25% is instilled intraperitoneal under direct vision to evaluate its analgesic effect.

Primary outcomes

  1. Postoperative Pain score assessed using the Visual Analog Scale .

    Time frame: 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.

  2. Time to First Analgesic Request

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Total Analgesic Consumption

    Time frame: within 24 hours after surgery

  2. Patient Satisfaction Score

    Time frame: 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.

  3. Length of Hospital Stay

    Time frame: 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.

  4. Time to First Patient Ambulation

    Time frame: Within 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Usama Ahmed Elsaeed Salem, MD

Other

Registry information

Official study title

Efficacy of the Analgesic Effect of Local Anesthetic Injection on Postoperative Pain in Gynecological Laparoscopic Surgeries: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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