Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

Pain, Postoperative Clinical Trial

— ESFIBHA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03860324
• Other study ID #: 45149
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Hospital Beatriz Ângelo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Single-shot erector spinae plane block
Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
• Single-shot fascia iliaca block
Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%

Locations

Country	Name	City	State
Portugal	Hospital Beatriz Ângelo	Loures	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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