Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block Versus Bilateral Lateral Quadratus Lumborum Plane Block in Controlling Postoperative Pain in Cancer Patients Undergoing Open Nephrectomy

NCT06889987 | Recruiting

• 1 other identifier: AP2412-201-088-194
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy.

Conditions

Bilateral; Ultrasound; Intramuscular Quadratus Lumborum Plane Block; Lateral Quadratus Lumborum Plane Block; Postoperative Pain; Cancer Patients; Open Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  The degree of pain will be assessed using the Visual Analogue Scale (VAS) where 0 (no pain) and 10 (the worst pain). VAS score in each technique at 0, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

  24 hours postoperatively

Secondary Outcomes (9)

• Total amount of morphine consumption

  24 hours postoperatively

• Total amount of fentanyl consumption

  Intraoperatively

• Change in heart rate

  24 hours postoperatively

• Change in mean arterial blood pressure

  24 hours postoperatively

• Incidence of postoperative nausea and vomiting

  24 hours postoperatively

Study Arms (3)

Intramuscular quadratus lumborum group

EXPERIMENTAL

Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia.

Drug: Intramuscular quadratus lumborum block

Lateral quadratus lumborum group

EXPERIMENTAL

Patients will receive bilateral Ultrasound-guided lateral quadratus lumborum with injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia.

Drug: Lateral quadratus lumborum block

Control group

ACTIVE COMPARATOR

Patients will receive only general anesthesia without any block

Drug: General anesthesia

Interventions

Intramuscular quadratus lumborum block DRUG

Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia

Also known as: Bupivacaine 0.25%

Intramuscular quadratus lumborum group

Lateral quadratus lumborum block DRUG

Patients will receive bilateral ultrasound-guided lateral quadratus lumborum with an injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia.

Also known as: Bupivacaine 0.25%

Lateral quadratus lumborum group

General anesthesia DRUG

Patients will receive only general anesthesia without any block.

Control group

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status II-III.
• Body mass index (BMI): (20- 40) kg/m2.
• Type of surgery: midline incision for unilateral open nephrectomy.

You may not qualify if:

• Patient refusal.
• Age \<18 years or \>65 years
• BMI \<20 kg/m2 and \> 40 kg/m2
• Known sensitivity or contraindication to drugs used in the study
• Contraindication to regional anesthesia, e.g. local infection at the introduction site, pre-existing peripheral neuropathies and coagulopathy.
• Physical status ASA IV
• Patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
• Patients with a history of drug abuse
• Patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
• All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Ahmed M Salama, Master

CONTACT

00201024275085; dr.Ahmed.ismail93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Pain Relief, and Intensive Care Unit, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: December 10, 2024
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)