Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

NCT ID: NCT03860324

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control-group

No peripheral nerve block

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Single-shot erector spinae plane block

Intervention Type: PROCEDURE

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

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%.

Group Type: ACTIVE_COMPARATOR

Single-shot fascia iliaca block

Intervention Type: PROCEDURE

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

Interventions

Single-shot erector spinae plane block

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

Intervention Type: PROCEDURE

Single-shot fascia iliaca block

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Beatriz Ângelo

OTHER

Sponsor Role: lead

Responsible Party

André Carrão

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André Carrão

Role: PRINCIPAL_INVESTIGATOR

Hospital Beatriz Ângelo

Locations

Hospital Beatriz Ângelo

Loures, Lisbon District, Portugal

Countries

Portugal

Other Identifiers

45149

Identifier Type: -

Identifier Source: org_study_id