Anterior Quadratus Lumborum Block as a Component of Multimodal Analgesia for Abdominal Hysterectomies

NCT07046949 | Completed

• 1 other identifier: 7-A/2812
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this randomised double-blinded controlled trial is to assess whether adding anterior quadratus lumborum block preoperatively can reduce intraoperative and postoperative opioid consumption, reduce pain after abdominal hysterectomy and improve quality of recovery after anesthesia. The study hypothesis is that anterior QL block bilaterally before the start of a surgery has no impact on perioperative pain relief, can't reduce the need in opioids and will not improve quality of recovery after anesthesia. All patients will undergo general anesthesia with tracheal intubation and mechanical ventilation. Patients will be randomized into two groups. In addition to general anesthesia and multimodal analgesia with parenteral medication II (QL) group will receive also anterior quadratus lumborum block as a regional component.

Conditions

Uterine Neoplasms; Uterine Diseases; Uterine Fibroids; Uterine Bleeding

Keywords

Regional anesthesia; Quadratus lumborum block; Abdominal hysterectomy; Pain scores; Multimodal analgesia; Acute pain; Chronic pain; Pain management; Opioid consumption; Quality of recovery; Postoperative nausea and vomiting; General anesthesia; Blended anesthesia; Hemodynamics after surgery

Outcome Measures

Primary Outcomes (3)

• Pain level after surgery

  It will be tested using visual analogue scale (VAS)

  It will be checked at the folowing stages of the study: 30 minutes (m30) 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the end of the surgery.

• Requirement of morphine for 24 hours

  The investigators will count a dose of morphine administered for patients of both groups postoperatively

  24 hours (h24), 48 hours (h48) after the surgery

• Intraoperative fentanyl consumption

  The investigators will compare fentanyl consumption between two groups, considering that the duration of surgeries differences won't be statistically significant.

  Intraoperative stage, at the end of the surgery (h0)

Secondary Outcomes (4)

• Quality of recovery after anesthesia

  The investigators will test it in 24 hours after the end of the surgery (h24)

• Postoperative nausea

  At 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24) after the end of the surgery

• Perioperative heart rate

  The investigators will evaluate parameters at intraoperative stage (h0), 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the surgery.

• Mean arterial pressure perioperatively

  The investigators will evaluate the parameters at intraoperative stage (h0), 30 minutes (m30), 6 hours (h6), 12 hours (h12), 24 hours (h24), 48 hours (h48) after the surgery.

Study Arms (2)

Group I (control)

ACTIVE COMPARATOR

Patients in Group I will undergo general anesthesia with tracheal intubation and mechanical ventilation. Analgesia regimen will include parenteral medication.

Drug: Parenteral administration of analgesics; Procedure: General Anesthesia (GA)

Group II (QL)

EXPERIMENTAL

Patients in Group II (QL) will undergo general anesthesia with tracheal intubation and mechanical ventilation. Analgesia regimen will include parenteral medication and anterior quadratus lumborum block as a regional component.

Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK; Drug: Parenteral administration of analgesics; Procedure: General Anesthesia (GA)

Interventions

ANTERİOR QUADRATUS LUMBORUM BLOCK PROCEDURE

Ultrasound-guided anterior QL block performed preoperatively

Group II (QL)

Parenteral administration of analgesics DRUG

Intravenous opioids or NSAIDs used perioperatively.

Group I (control); Group II (QL)

General Anesthesia (GA) PROCEDURE

Standard general anesthesia per continious 1% propofol infusion and propofol bolus administration, atracurium and fentanyl administration.

Group I (control); Group II (QL)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with ASA status I-II
• patients with symptomatic fibroids
• patients scheduled for abdominl hysterectomy

You may not qualify if:

• refusal to participate in the study at any of its stages
• ASA class ≥ III
• body mass index \> 40 kg/m2
• use of opiate receptor agonists/antagonists before surgery
• uncontrolled hypertension

Sponsors & Collaborators

• Danylo Halytsky Lviv National Medical University: collaborator
• Yuri Semenyuk Rivne Regional Clinical Hospital: lead

Study Sites (1)

Yuri Semenyuk Rivne regional cinical hospital

Rivne, Rivne Oblast, 33007, Ukraine

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Uterine Neoplasms; Uterine Diseases; Leiomyoma; Acute Pain; Chronic Pain; Agnosia; Postoperative Nausea and Vomiting

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Postoperative Complications; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Olha Filyk, Professor

  Danylo Halytsky Lviv National Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm parallel group design in which participants are randomly allocated to receive either general anesthesia and multimodal analgesia without QL-block or general anesthesia and multimodal analgesia including QL-block.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 2, 2025
• Study Start: July 7, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 11, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

UA (1)