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

Not Applicable

Completed

• Conditions: Lumbosacral; Erector Spinae Plane Block; Psoas Muscle Compartment Block; Sciatic Nerve Block; Anesthesia; Unilateral; Lower Limb; Critically Ill Patients
• Interventions: Drug: Lumbosacral Erector Spinae Plane Block; Drug: Psoas Muscle Compartment With Sciatic Nerve Block

• Registration Number: NCT06580704
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2024-08-24
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Study Start: 2024-08-31
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbosacral Erector Spinae Plane Block	Lumbosacral Erector Spinae Plane Block	Patients will receive ultrasound-guided lumbosacral erector spinae plane block.
Psoas Muscle Compartment With Sciatic Nerve Block	Psoas Muscle Compartment With Sciatic Nerve Block	Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hear rate	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.
Mean arterial pressure	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.
Duration of analgesia	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.
Degree of pain	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.
Degree of patient satisfaction	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).
Incidence of adverse events	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt