ESP Block vs FIB in Patients Undergoing Hip Arthroplasty

NCT ID: NCT05015517

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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Hip arthroplasty surgery is usually associated with severe postoperative pain. Several modalities are usually used for postoperative analgesia in these patients, those include; intravenous analgesia, neuraxial analgesia and peripheral nerve blocks.

Peripheral nerve blocks have several advantages such as; potent analgesia, lower motor impairment and minimal systemic complications.

Lumbar plexus block and supra-inguinal fascia iliaca block (FIB) are the most commonly performed peripheral nerve blocks for hip surgeries.

Fascia iliaca block is one of the most common techniques for pain control after hip surgeries; it can be regarded as an anterior approach of the lumbar plexus. It provides analgesia through spread of local anaesthetic to the femoral and lateral cutaneous femoral nerves.

Ultrasound guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described in 2016 for acute and chronic thoracic pain management. It is a paraspinal fascial plane block that provides analgesia through injecting local anesthetic drugs to block the ventral and dorsal rami of spinal nerves in the paravertebral area.

To the best of the investigators knowledge, the use of ESP block in hip surgery was only investigated in one study and few case reports. Therefore, further randomized controlled studies are needed to prove this hypothesis.

This study aims to investigate the efficacy of ESP block in hip replacement compared to the supra-inguinal FIB.

The investigators hypothesize that erector spinae block may provide better postoperative analgesia than fascia iliaca block, since erector spinae block provides analgesic cover for the entire lumbar plexus rather than just peripheral nerves provided by fasicia iliaca.

Conditions

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Hip Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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ESPB Group

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

Group Type ACTIVE_COMPARATOR

Erector spinae plain block

Intervention Type 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

FIB Group

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

Group Type ACTIVE_COMPARATOR

Fascia Iliaca block

Intervention Type 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.

Interventions

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Erector spinae plain block

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

Intervention Type PROCEDURE

Fascia Iliaca block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Abdallah Moawad

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf RA Aswa, Professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Ahmed MA Moawad, Ass.lecturer

Role: CONTACT

01098189096 ext. +2

Sheren Refaat, A.Professor

Role: CONTACT

01005607829 ext. +2

Related Links

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https://journals.lww.com/anesthesia-analgesia/fulltext/2002/06000/continuous_psoas_compartment_block_for.45.aspx

Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation

https://search.proquest.com/openview/70d234ac1634867694810005281fe12a/1?pq-origsite=gscholar&cbl=226517

Erector spinae plane block an effective block for postoperative analgesia in modified radical mastectomy.

Other Identifiers

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ESP vs FIB in hip arthroplasty

Identifier Type: -

Identifier Source: org_study_id

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