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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Erector Spinae Plane Block; Critically Ill Patients; Lower Limb; Sciatic Nerve Block; Unilateral; Lumbosacral; Psoas Muscle Compartment Block
• Intervention / Treatment: Drug: Lumbosacral Erector Spinae Plane Block; Drug: Psoas Muscle Compartment With Sciatic Nerve Block

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbosacral Erector Spinae Plane Block; Patients will receive ultrasound-guided lumbosacral erector spinae plane block.	Drug: Lumbosacral Erector Spinae Plane Block; Patients will receive ultrasound-guided lumbosacral erector spinae plane block.
Experimental: Psoas Muscle Compartment With Sciatic Nerve Block; Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.	Drug: Psoas Muscle Compartment With Sciatic Nerve Block; Patients will receive ultrasound-guided psoas muscle compartment with sciatic nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hear rate	Hear rate will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.	Every 15 minutes till the end of surgery (up to 2 hours)
Mean arterial pressure	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery.	Every 15 minutes till the end of surgery (up to 2 hours)
Duration of analgesia	Duration of analgesia (time from the injection of anesthetic solution to the first request of rescue analgesic drug) will be assessed.	Till the first request of rescue analgesic drug (up to 24 hours after surgery)
Degree of pain	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.	24 hours postoperatively
Degree of patient satisfaction	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).	24 hours postoperatively
Incidence of adverse events	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.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: August 24, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 36264PR761/7/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No