ESP Block vs FIB in Patients Undergoing Hip Arthroplasty

NCT05015517 | Unknown

• 1 other identifier: ESP vs FIB in hip arthroplasty
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare between the analgesic efficacy of ESP block and FIB in patients undergoing hip arthroplasty.

Conditions

Hip Arthropathy

Keywords

Erector spinae block; Fascia iliaca block

Outcome Measures

Primary Outcomes (1)

• Total morphine requirements

  Amount of morphine required postoperatively

  24 hours postoperatively

Secondary Outcomes (3)

• Visual analogue pain score

  at rest at 2, 4, 6, 12, 18, and 24 hours postoperatively

• Time to first postoperative analgesic request

  24 hours postoperatively

• Quadriceps muscle power strength

  at 6, 12 and 24 hours postoperatively

Study Arms (2)

ESPB Group

ACTIVE COMPARATOR

This group will receive ultrasound-guided erector spinae plane block and subarachnoid block.

Procedure: Erector spinae plain block

FIB Group

ACTIVE COMPARATOR

This group will receive supra-inguinal fascia iliaca block and subarachnoid block .

Procedure: Fascia Iliaca block

Interventions

Erector spinae plain block PROCEDURE

Patients will be placed in the lateral position.Ultrasonography will be performed by an experienced anesthetist.The 4th lumbar vertebral level will be determined using the conventional method (imaginary line between two iliac crests). The low frequency convex probe (2-5MHz) will then be placed at the mid-vertebral line in the sagittal plane. It will be shifted from the midline, 3.5-4 cm lateral to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-plane technique a 22G/80-mm block needle will be advanced until it reaches the transverse process. After negative aspiration, 0.5-1 ml of the prepared local anaesthetic solution (20 ml bupivacaine 0.5%, 10 ml lidocaine 2%) and 10 ml normal saline will be administered for hydrodissection to confirm correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when injecting local anesthesia

ESPB Group

Fascia Iliaca block PROCEDURE

Patients will be placed in supine position. Ultrasonography will be performed by an experienced anesthetist using ultrasound device equipped with a low frequency (2-5 MHz) convex probe and an echogenic 21 G/ 10 cm needle will be used. The probe will be placed in the inguinal crease. Scan will be started laterally from the femoral artery and nerve in the inguinal crease to identify the Sartorius muscle. The muscle will then be traced until its origin at the anterior superior iliac spine is identified and the shadow of the bony of iliac crest \& iliacus muscle will be seen. Injection will be performed at the plane deep to the fascia iliaca and above the lateral part of the iliacus muscle. After negative aspiration, the prepared local anaesthetic solution (15 ml bupivacaine 0.5%, 15 ml normal saline) will be injected incrementally, aspirating every 5 ml.

FIB Group

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years
• ASA grade I to II
• Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty

You may not qualify if:

• Patient refusal
• Age below 18 or above 65 years.
• ASA grade III to IV
• Patients with known allergies to any of the drugs used.
• Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies.
• Patients receiving opioids for chronic analgesic therapy
• Inability to comprehend visual analogue scale (VAS)
• Infection at site of erector spinae or fascia iliaca block.
• Body mass index \>35 kg/m2

Sponsors & Collaborators

• Cairo University: lead

Related Links

• Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation
• Abrahams MS, Aziz MF. Ambulatory continuous posterior lumbar plexus blocks following hip arthroscopy: a review of 213 cases
• Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty
• Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty
• The erector spinae plane block: a novel analgesic technique in thoracic neuropathic pain.
• Erector spinae plane block an effective block for postoperative analgesia in modified radical mastectomy.

Study Officials

• Ashraf RA Aswa, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed MA Moawad, Ass.lecturer

CONTACT

01098189096; ahmedmohammed621991@gmail.com

Sheren Refaat, A.Professor

CONTACT

01005607829; Sherin.refaat@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: computer-generated sequence. Concealment will be achieved using opaque envelopes. All data will be collected blindly and the authors will perform the blocks without interference in data collection.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08