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Completed

NCT Number: NCT06580704

Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients

This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

The lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. Regional anesthesia is often used to prevent postoperative pain. Ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system.

Psoas compartment block (PCB) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. In combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability.

The erector Spinae plane block (ESPB) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.

Who can participate

Healthy volunteers accepted: No

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

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status III, IV.
  • Critically ill patients admitted to intensive care unit.
  • Undergoing unilateral lower limb operations.

Exclusion criteria

  • History of allergy to local anesthetics.
  • Bleeding tendency.
  • Coagulopathy.
  • Anticoagulant therapy.
  • Pre-existing psychological, neurologic, and spinal cord diseases.
  • Previous back surgery.
  • Infection or mass at the site of the block.
  • Chronic analgesic therapy.
  • Severe cardiac or renal diseases.

Treatment and study plan

Lumbosacral Erector Spinae Plane Block

Drug

Patients will receive ultrasound-guided lumbosacral erector spinae plane block.

Psoas Muscle Compartment With Sciatic Nerve Block

Drug

Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.

Primary outcomes

  1. Incidence of failure

    Time frame: Intraoperatively

    Incidence of failure will be recorded. After 30minutes, the pinprick test will be performed. If pain persists, the patient will be excluded.

Secondary outcomes

  1. Hear rate

    Time frame: Every 15 minutes till the end of surgery (up to 2 hours)

    Hear rate will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.

  2. Mean arterial pressure

    Time frame: Every 15 minutes till the end of surgery (up to 2 hours)

    Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.

  3. Duration of analgesia

    Time frame: Till the first request of rescue analgesic drug (up to 24 hours after surgery)

    Duration of analgesia (time from the injection of anesthetic solution to the first request of rescue analgesic drug) will be assessed.

  4. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 2, 4, 6, 8, 12, and 24 h postoperatively.

  5. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

  6. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, postoperative nausea and vomiting (PONV), hematoma, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients: A Randomized Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Apr 15, 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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