Interfascial Abdominal Wall Block for Gynecological Laparoskopy: A Randomized Clinical Trial

NCT07705516 | Completed

• 1 other identifier: Protocol №17-01/06/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of combining ultrasound-guided bilateral rectus sheath blocks (RSB) and quadratus lumborum blocks (QLB) compared to using a quadratus lumborum block alone for postoperative analgesia in patients undergoing laparoscopic gynecological surgeries. The primary objective is to assess movement-evoked pain scores in the early postoperative period. Secondary objectives include the evaluation of postoperative opioid consumption, intraoperative hemodynamic stability, and the overall incidence of side effects. Investigators hypothesize that the combined interfacial abdominal wall block technique will provide superior pain relief and reduce opioid requirements during recovery.

Conditions

Postoperative Pain; Pelvic Pain

Keywords

Quadratus Lumborum Block; Rectus Sheath Block; Laparoscopy; Gynecologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Visual Analog Scale (VAS) score. Scale from 0 to 10. 0 means no pain. 10 means worst pain. Lower scores sindicate less pain.

  At 2, 4, 6, 12, and 24 hours postoperative assessment

Secondary Outcomes (1)

• Total opioid consumption. Postoperative period. Measured in milligrams.

  Within 24 hours after surgery.

Study Arms (2)

QLB + RSB Group

EXPERIMENTAL

Combined regional anesthesia. Bilateral QL block technique. Bilateral RSB technique. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management.

Procedure: Bilateral QLB and RSB

QLB Group

ACTIVE COMPARATOR

Isolated regional anesthesia. Bilateral QLB technique. No rectus sheath block. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management.

Procedure: Bilateral QLB alone

Interventions

Bilateral QLB and RSB PROCEDURE

Preoperative regional anesthesia. Bilateral QL block combined with bilateral RS block. Ultrasound-guided technique. Using local anesthetics.

QLB + RSB Group

Bilateral QLB alone PROCEDURE

Preoperative regional anesthesia. Isolated bilateral QL block. No rectus sheath block. Ultrasound-guided technique. Using local anesthetics.

QLB Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective gynecological video-laparoscopic surgery.
• ASA physical status І-ІІ.
• Age between 18 and 65 years.
• Patient's informed consent to participate in the study

You may not qualify if:

• Known allergy or contraindications to local anesthetics.
• Infection at the potential needle insertion sites.
• Coagulopathy or ongoing anticoagulant therapy.
• Conversion to open laparotomy during surgery.
• Severe cognitive impairment or psychiatric disorders.

Sponsors & Collaborators

• Medical and Diagnostic Center "MEDION" LLC: lead

Study Sites (1)

Medical and Diagnostic Center "MEDION" LLC

Poltava, Poltava Oblast, 36039, Ukraine

Location

MeSH Terms

Conditions

Pain, Postoperative; Pelvic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: January 7, 2025
• Primary Completion: December 27, 2025
• Study Completion: December 28, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)