Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty (ESFIBHA)

Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery

The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.

Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.

The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Single-shot erector spinae plane block; Procedure: Single-shot fascia iliaca block

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa
    • Loures, Lisboa, Portugal, 2674-514
      • Hospital Beatriz Ângelo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Surgical plan for total hip replacement
• Signing of consent form to participate in the study

Exclusion Criteria:

• Patient refusal
• BMI > 40 kg/m2
• Surgical plan for revision of hip replacement
• Patient unable to quantify pain level
• Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min
• Previously medicated with opioids
• Patient unable to perform the surgery with spinal block
• Allergy to local anesthetics
• Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
• Allergy or contraindication to the use of morphine

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control-group; No peripheral nerve block
Experimental: Single-shot erector spinae plane block; The patient is positioned in lateral decubitus. The anesthesiologist uses a linear high-frequency probe in a longitudinal direction laterally to the mid-sagittal plane at the level of L4 until the transverse process is identified and, more superficial, the erector spinae muscle. A 22G needle of 80mm is introduced in-plane craniocaudally towards the transverse process of L4 until its tip is in the plane deep to the erector spinae muscle. Single-shot block with 30ml of ropivacaine 0,5% + adrenaline 100mcg	Procedure: Single-shot erector spinae plane block; Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
Active Comparator: Single-shot fascia iliaca block; The patient is positioned in dorsal decubitus. The anesthesiologist uses a linear high-frequency probe in a transversal direction, below the crural arch so as to identify the femoral artery. Afterwards the probe is moved laterally to find the iliac muscle and its fascia. A 22G needle of 80mm is introduced in-plane latero-medially until its tip is below the fascia iliaca (between the muscle and its fascia). Single-shot block with 40ml of ropivacaine 0,2%.	Procedure: Single-shot fascia iliaca block; Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain level measured by the Visual Analog Scale	Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)	At 6 hours post-operative
Post-operative pain level measured by the Visual Analog Scale	Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)	At 12 hours post-operative
Post-operative pain level measured by the Visual Analog Scale	Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)	At 24 hours post-operative
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia	Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes	At 24 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength grade	Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle Muscle strength scale: Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance	At 12 hours post-operative
Muscle Strength grade	Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle Muscle strength scale: Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance	At 24 hours post-operative
Sensory block assessed through a temperature test	Assessment of sensory block through a temperature test and comparison with the contralateral limb (sensory block vs no sensory block)	At 24 hours post-operative
Sensory block assessed through a tactile stimulation test	Assessment of sensory block through a tactile stimulation test and comparison with the contralateral limb (sensory block vs no sensory block)	At 24 hours post-operative
Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient	Presence of side effects (pruritus, urinary retention, nausea/vomiting)	At 24 hours post-operative

Collaborators and Investigators

• Sponsor: Hospital Beatriz Ângelo
• Investigators: Principal Investigator: André Carrão, Hospital Beatriz Ângelo

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hip Arthroplasty; Erector Spinae Plane Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 45149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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