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Recruiting NCT06889987

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

No phase Interventional Bilateral Ultrasound Intramuscular Quadratus Lumborum Plane Block Lateral Quadratus Lumborum Plane Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intramuscular quadratus lumborum block, Lateral quadratus lumborum block, General anesthesia.
Who it may be relevant to
Registry conditions: Bilateral, Ultrasound, Intramuscular Quadratus Lumborum Plane Block, Lateral Quadratus Lumborum Plane Block. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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
  • 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.
  • Drug General anesthesia
    Patients will receive only general anesthesia without any block.

Primary outcome measures

  • Degree of pain [Time frame: 24 hours postoperatively]
Secondary outcome measures (9)
  • Total amount of morphine consumption [Time frame: 24 hours postoperatively]
  • Total amount of fentanyl consumption [Time frame: Intraoperatively]
  • Change in heart rate [Time frame: 24 hours postoperatively]
  • Change in mean arterial blood pressure [Time frame: 24 hours postoperatively]
  • Incidence of postoperative nausea and vomiting [Time frame: 24 hours postoperatively]
  • Time of first rescue analgesia [Time frame: 24 hours postoperatively]
  • Incidence of complications related to block [Time frame: 24 hours postoperatively]
  • Incidence of morphine related complications [Time frame: 24 hours postoperatively]
  • Degree of patient satisfaction [Time frame: 24 hours postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • National Cancer Institute — Cairo

Identifiers

NCT: NCT06889987 · AP2412-201-088-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗