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

Not Applicable

Recruiting

• Conditions: Bilateral; Ultrasound; Intramuscular Quadratus Lumborum Plane Block; Lateral Quadratus Lumborum Plane Block; Postoperative Pain; Cancer Patients; Open Nephrectomy
• Interventions: Drug: Intramuscular quadratus lumborum block; Drug: Lateral quadratus lumborum block; Drug: General anesthesia

• Registration Number: NCT06889987
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Study Start: 2024-12-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-16
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-12-06
• Study Completion: 2025-12-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular quadratus lumborum group	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.
Lateral quadratus lumborum group	Lateral quadratus lumborum block	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.
Control group	General anesthesia	Patients will receive only general anesthesia without any block

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Total amount of morphine consumption	24 hours postoperatively	Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
Total amount of fentanyl consumption	Intraoperatively	Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Change in heart rate	24 hours postoperatively	Change in heart rate will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Change in mean arterial blood pressure	24 hours postoperatively	Change in mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Incidence of postoperative nausea and vomiting	24 hours postoperatively	Incidence of postoperative nausea and vomiting will be recorded.
Time of first rescue analgesia	24 hours postoperatively	Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Incidence of complications related to block	24 hours postoperatively	Incidence of complications related to block such as local anesthetic systemic toxicity and arterial puncture will be recorded.
Incidence of morphine related complications	24 hours postoperatively	Incidence of morphine-related complications such as respiratory depression, urine retention or pruritis will be recorded.
Degree of patient satisfaction	24 hours postoperatively	The patient will be classified in this group to be satisfied or not.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt