Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block After Total Hip Arthroplasty

Comparative Study Between Ultrasound-Guided Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block for Postoperative Analgesia After Total Hip Arthroplasty

Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Drug: spinal anesthesia plane block; Drug: Lumbar Erector spinae plane block (L-ESPB); Drug: Fascia iliaca compartment block (FICB)

Detailed Description

Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Ahmed Zahran, MBBCH; Phone Number: +20 101 997 6377; Email: ahmad162088@med.tanta.edu.eg

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31527
      • Recruiting
      • Tanta University hospitals
      • Contact: Ahmed A Zahran, MBBCh; Phone Number: +20 101 997 6377; Email: ahmad162088@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients aged 30-75 years from both sexes.
2. ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.

Exclusion Criteria:

1. Patients' refusal.
2. Patients who were unable to co-operate with researchers.
3. History of allergy to local anesthetics.
4. Local infection at the site of the block.
5. Patients with bleeding and coagulation disorders.
6. Patients with renal, hepatic, cardiac decompensation, or spine deformities.
7. Patients receiving opioids for chronic analgesic therapy
8. Body mass index > 35 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Patients will receive spinal anesthesia alone (30 ml bupivacaine 0. 25%).	Drug: spinal anesthesia plane block; Patients will receive spinal anesthesia alone
Active Comparator: Lumbar Erector spinae plane block (L-ESPB); Patients will receive spinal anesthesia and then ipsilateral lumbar erector spinae plane block (30 ml bupivacaine 0. 25%) at the level of the lumbar region in the operating room after the end of the surgery.	Drug: Lumbar Erector spinae plane block (L-ESPB); The fourth lumbar vertebral level will be determined using the conventional method (the imaginary line between two crista iliacas). The convex transducer will be placed at the mid-vertebral line in the sagittal plane. The transducer will be shifted from the midline, 3.5-4 cm laterally, to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-of-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthesia solution (30 ml bupivacaine 0.25%) will be administered, leading to hydro dissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when administering local anesthesia. All local anesthesia will be administered to this location between the transverse process and the erector spinae muscle
Active Comparator: Fascia iliaca compartment block (FICB); Patients will receive spinal anesthesia and then ipsilateral suprainguinal fascia iliaca compartment block (30 ml bupivacaine 0. 25%) in the operating room after the end of the surgery.	Drug: Fascia iliaca compartment block (FICB); The transducer will be placed laterally to the femoral nerve. It then rotated 90 degrees to the sagittal plane, under ultrasound guidance, a regional block needle (22 G, 80 mm) will be introduced in the cranial direction. Once good needle alignment with the ultrasound beam is achieved, the needle will be inserted deep into the tissues until an optimal position of the needle tip is obtained. Needle location will be additionally verified by injecting 0.5-1 ml of the prepared local anesthesia solution and observing the solution spread within the tissues. Once the correct position of the needle tip is confirmed, the local anesthetic will be deposited under the iliac fascia to force its flow towards the lumbar plexus. 30 ml of bupivacaine 0.25% solution will be used for the block. local anesthesia will be administered as 5 mL boluses with a 20 second interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of postoperative pain	Assessment of postoperative pain using the Numeric rating scale (NRS), NRS is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain)	UP to 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for the first rescue analgesia.	Morphine sulfate 0.03 mg/kg will be administered intravenous as a rescue analgesic if Numeric rating scale is ≥ 4	Up to 24 hours postoperatively
The total postoperative rescue analgesic	The total amount of morphine consumption	first 24 hours postoperatively
Adverse effects	Any complications or undesirable side effects will be observed and treated.	Up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 35153/12/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author from one year after study completion
• IPD Sharing Time Frame: From one year after study completion
• IPD Sharing Access Criteria: The data will be available upon 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
• product manufactured in and exported from the U.S.: Yes