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

NCT06580704 | Completed

• 1 other identifier: 36264PR761/7/24
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of failure

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

  Intraoperatively

Secondary Outcomes (6)

• Hear rate

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

• Mean arterial pressure

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

• Duration of analgesia

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

• Degree of pain

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (2)

Lumbosacral Erector Spinae Plane Block

EXPERIMENTAL

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

Drug: Lumbosacral Erector Spinae Plane Block

Psoas Muscle Compartment With Sciatic Nerve Block

EXPERIMENTAL

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

Drug: Psoas Muscle Compartment With Sciatic Nerve Block

Interventions

Lumbosacral Erector Spinae Plane Block DRUG

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

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.

Psoas Muscle Compartment With Sciatic Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: August 30, 2024
• Study Start: August 31, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)