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NCT Number: 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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Ahmed M Salama, Master

CONTACT

[email protected]

00201024275085

Ahmed S Ragab, MD

SUB_INVESTIGATOR

Mohamed A El-Ramli, MD

SUB_INVESTIGATOR

Noha M Abd El-Monem, MD

SUB_INVESTIGATOR

Osama M El-Bosraty, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intramuscular quadratus lumborum block

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

Other names: Bupivacaine 0.25%

Lateral quadratus lumborum block

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.

Other names: Bupivacaine 0.25%

General anesthesia

Drug

Patients will receive only general anesthesia without any block.

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Total amount of morphine consumption

    Time frame: 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.

  2. Total amount of fentanyl consumption

    Time frame: 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.

  3. Change in heart rate

    Time frame: 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.

  4. Change in mean arterial blood pressure

    Time frame: 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.

  5. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperatively

    Incidence of postoperative nausea and vomiting will be recorded.

  6. Time of first rescue analgesia

    Time frame: 24 hours postoperatively

    Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

  7. Incidence of complications related to block

    Time frame: 24 hours postoperatively

    Incidence of complications related to block such as local anesthetic systemic toxicity and arterial puncture will be recorded.

  8. Incidence of morphine related complications

    Time frame: 24 hours postoperatively

    Incidence of morphine-related complications such as respiratory depression, urine retention or pruritis will be recorded.

  9. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    The patient will be classified in this group to be satisfied or not.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Salama, Master

CONTACT

[email protected]

00201024275085

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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