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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-03-30

Brief Summary

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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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Detailed Description

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Conditions

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Gynecologic Laparoscopic Surgery Postoperative Pain Recovery Outcomes Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Port Site Local Anesthetic Injection (Group A)

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

Group Type EXPERIMENTAL

Bupivacaine 0.25%

Intervention Type DRUG

Before trocar insertion in gynecologic laparoscopic surgery, 5 mL of Bupivacaine 0.25% is infiltrated subcutaneously at each trocar port site to assess its effect on postoperative pain.

Intraperitoneal Local Anesthetic Injection (Group B)

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

Group Type EXPERIMENTAL

Bupivacaine 0.25%

Intervention Type 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.

Control (Group C)

Participants receive no local anesthetic injection during surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine 0.25%

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.

Intervention Type DRUG

Bupivacaine 0.25%

Before trocar insertion in gynecologic laparoscopic surgery, 5 mL of Bupivacaine 0.25% is infiltrated subcutaneously at each trocar port site to assess its effect on postoperative pain.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No