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

NCT07030647 | Completed DMC

• 1 other identifier: MS-447-2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gynecological laparoscopy, local anesthetic infiltration, postoperative pain, recovery, bupivacaine, port-site infiltration; Intraperitoneal local anesthetic

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain score assessed using the Visual Analog Scale .

  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.

  24 hours after surgery

• Time to First Analgesic Request

  24 hours after surgery

Secondary Outcomes (4)

• Total Analgesic Consumption

  within 24 hours after surgery

• Patient Satisfaction Score

  24 hours postoperatively

• Length of Hospital Stay

  From end of surgery until hospital discharge assessed up to 7 days

• Time to First Patient Ambulation

  Within 24 hours after surgery

Study Arms (3)

Port Site Local Anesthetic Injection (Group A)

EXPERIMENTAL

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

Drug: Bupivacaine 0.25%

Intraperitoneal Local Anesthetic Injection (Group B)

EXPERIMENTAL

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

Drug: Bupivacaine 0.25%

Control (Group C)

NO INTERVENTION

Participants receive no local anesthetic injection during surgery.

Interventions

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.

Intraperitoneal Local Anesthetic Injection (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Usama Ahmed Elsaeed Salem, MD: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Location

Related Publications (1)

• Elsaeed UA, Algyoushy EAFIH, Hatem DLM. Effect of port-site and intraperitoneal local anesthetic injection versus placebo on postoperative pain and recovery after gynecologic laparoscopic surgery: a randomized controlled trial. Sci Rep. 2025 Sep 12;15(1):32466. doi: 10.1038/s41598-025-18389-w.

  PMID: 40940430 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Usama Ahmed Elsaeed Salem, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 22, 2025
• Study Start: March 1, 2024
• Primary Completion: February 5, 2025
• Study Completion: March 30, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 Months after publication of study results for a year.
• Access Criteria: Data will be shared upon reasonable request by contacting the corresponding author. Researchers must sign a data use agreement to access the data.

Locations

EG (1)