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

NCT ID: NCT06889987

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2025-12-06

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.

Detailed Description

Post-surgical somatic pain is very distressing to patients, which may lead to significant complications.

Practitioners initially used these as ilioinguinal, iliohypogastric, rectus sheath blocks, and in the early 21st century, transversus abdominis plane (TAP) blocks. A recent variation of the TAP block is known as the quadratus lumborum block (QLB).

The QL block effectiveness is believed to result from the spread of Local Anesthetic cranially from the lumbar deposition into the thoracic paravertebral space (TPVS). So, the QLB seems to relieve somatic and visceral pains.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intramuscular quadratus lumborum group

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.

Group Type: EXPERIMENTAL

Intramuscular quadratus lumborum block

Intervention Type: 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

Lateral quadratus lumborum group

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.

Group Type: EXPERIMENTAL

Lateral quadratus lumborum block

Intervention Type: 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.

Control group

Patients will receive only general anesthesia without any block

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: DRUG

Patients will receive only general anesthesia without any block.

Interventions

Intramuscular quadratus lumborum block

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

Intervention Type: DRUG

Lateral quadratus lumborum block

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.

Intervention Type: DRUG

General anesthesia

Patients will receive only general anesthesia without any block.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine 0.25%; Bupivacaine 0.25%

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ismail

Assistant Lecturer of Anesthesia, Pain Relief, and Intensive Care Unit, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M Salama, Master

Role: CONTACT

dr.Ahmed.ismail93@gmail.com

00201024275085

Facility Contacts

Ahmed M Salama, Master

Role: primary

dr.Ahmed.ismail93@gmail.com

00201024275085

Other Identifiers

AP2412-201-088-194

Identifier Type: -

Identifier Source: org_study_id