Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bilateral
Ultrasound
Intramuscular Quadratus Lumborum Plane Block
Lateral Quadratus Lumborum Plane Block
Postoperative Pain
Cancer Patients
Open Nephrectomy
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total amount of morphine consumption
timeFrame: 24 hours postoperatively
measure: Total amount of fentanyl consumption
timeFrame: Intraoperatively
measure: Change in heart rate
timeFrame: 24 hours postoperatively
measure: Change in mean arterial blood pressure
timeFrame: 24 hours postoperatively
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours postoperatively
measure: Time of first rescue analgesia
timeFrame: 24 hours postoperatively
measure: Incidence of complications related to block
timeFrame: 24 hours postoperatively
measure: Incidence of morphine related complications
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
References: