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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06580704
Enrollment
130
Registered
2024-08-30
Start date
2024-08-31
Completion date
2025-03-26
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Critically Ill Patients, Erector Spinae Plane Block, Lower Limb, Lumbosacral, Psoas Muscle Compartment Block, Sciatic Nerve Block, Unilateral

Brief summary

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.

Detailed description

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.

Interventions

DRUGLumbosacral Erector Spinae Plane Block

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

DRUGPsoas Muscle Compartment With Sciatic Nerve Block

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Mean arterial pressureEvery 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.
Duration of analgesiaTill 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.
Hear rateEvery 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.
Degree of patient satisfaction24 hours postoperativelyThe 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).
Incidence of adverse events24 hours postoperativelyIncidence 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.
Degree of pain24 hours postoperativelyEach 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026