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

Efficacy of Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block (Ql4) Versus Bilateral Lateral Quadratus Lumborum Plane Block (Ql1) in Controlling Post-Operative Pain in Cancer Patient Undergoing Open Nephrectomy: A Randomized Control Study

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Salama, Master; Phone Number: 00201024275085; Email: dr.Ahmed.ismail93@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute
    • Sub-Investigator: Ahmed S Ragab, MD
    • Contact: Ahmed M Salama, Master; Phone Number: 00201024275085; Email: dr.Ahmed.ismail93@gmail.com
    • Sub-Investigator: Mohamed A El-Ramli, MD
    • Sub-Investigator: Noha M Abd El-Monem, MD
    • Sub-Investigator: Osama M El-Bosraty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Bupivacaine 0.25%
Experimental: 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.	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.; Other Names: Bupivacaine 0.25%
Active Comparator: Control group; Patients will receive only general anesthesia without any block	Drug: General anesthesia; Patients will receive only general anesthesia without any block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of fentanyl consumption	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.	Intraoperatively
Total amount of morphine consumption	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.	24 hours postoperatively
Change in heart rate	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.	24 hours postoperatively
Change in mean arterial blood pressure	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.	24 hours postoperatively
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting will be recorded.	24 hours postoperatively
Time of first rescue analgesia	Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.	24 hours postoperatively
Incidence of complications related to block	Incidence of complications related to block such as local anesthetic systemic toxicity and arterial puncture will be recorded.	24 hours postoperatively
Incidence of morphine related complications	Incidence of morphine-related complications such as respiratory depression, urine retention or pruritis will be recorded.	24 hours postoperatively
Degree of patient satisfaction	The patient will be classified in this group to be satisfied or not.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): December 6, 2025
• Study Completion (Estimated): December 6, 2025

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: AP2412-201-088-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No