Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

NCT03860324 | Withdrawn

• 1 other identifier: 45149
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain, Postoperative

Keywords

Hip Arthroplasty; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Muscle Strength grade

  At 12 hours post-operative

• Muscle Strength grade

  At 24 hours post-operative

• Sensory block assessed through a temperature test

  At 24 hours post-operative

• Sensory block assessed through a tactile stimulation test

  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

  At 24 hours post-operative

Study Arms (3)

Control-group

NO INTERVENTION

No peripheral nerve block

Single-shot erector spinae plane block

EXPERIMENTAL

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 fascia iliaca block

ACTIVE COMPARATOR

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

Interventions

Single-shot erector spinae plane block PROCEDURE

Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.

Single-shot erector spinae plane block

Single-shot fascia iliaca block PROCEDURE

Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%

Single-shot fascia iliaca block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Beatriz Ângelo: lead

Study Sites (1)

Hospital Beatriz Ângelo

Loures, Lisbon District, 2674-514, Portugal

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• André Carrão

  Hospital Beatriz Ângelo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 1, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)