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

Primary Purpose

Pain, Postoperative

Status
Withdrawn
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Single-shot erector spinae plane block
Single-shot fascia iliaca block
Sponsored by
Hospital Beatriz Ângelo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Hip Arthroplasty, Erector Spinae Plane Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Beatriz Ângelo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Control-group

Single-shot erector spinae plane block

Single-shot fascia iliaca block

Arm Description

No peripheral nerve 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

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%.

Outcomes

Primary Outcome Measures

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)
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)
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)
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

Secondary Outcome Measures

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
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
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)
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)
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)

Full Information

First Posted
February 24, 2019
Last Updated
August 24, 2021
Sponsor
Hospital Beatriz Ângelo
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1. Study Identification

Unique Protocol Identification Number
NCT03860324
Brief Title
Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Cancelled
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Beatriz Ângelo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Hip Arthroplasty, Erector Spinae Plane Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control-group
Arm Type
No Intervention
Arm Description
No peripheral nerve block
Arm Title
Single-shot erector spinae plane block
Arm Type
Experimental
Arm Description
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
Arm Title
Single-shot fascia iliaca block
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Single-shot erector spinae plane block
Intervention Description
Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
Intervention Type
Procedure
Intervention Name(s)
Single-shot fascia iliaca block
Intervention Description
Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%
Primary Outcome Measure Information:
Title
Post-operative pain level measured by the Visual Analog Scale
Description
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)
Time Frame
At 6 hours post-operative
Title
Post-operative pain level measured by the Visual Analog Scale
Description
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)
Time Frame
At 12 hours post-operative
Title
Post-operative pain level measured by the Visual Analog Scale
Description
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)
Time Frame
At 24 hours post-operative
Title
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia
Description
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
Time Frame
At 24 hours post-operative
Secondary Outcome Measure Information:
Title
Muscle Strength grade
Description
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
Time Frame
At 12 hours post-operative
Title
Muscle Strength grade
Description
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
Time Frame
At 24 hours post-operative
Title
Sensory block assessed through a temperature test
Description
Assessment of sensory block through a temperature test and comparison with the contralateral limb (sensory block vs no sensory block)
Time Frame
At 24 hours post-operative
Title
Sensory block assessed through a tactile stimulation test
Description
Assessment of sensory block through a tactile stimulation test and comparison with the contralateral limb (sensory block vs no sensory block)
Time Frame
At 24 hours post-operative
Title
Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient
Description
Presence of side effects (pruritus, urinary retention, nausea/vomiting)
Time Frame
At 24 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Carrão
Organizational Affiliation
Hospital Beatriz Ângelo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Beatriz Ângelo
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

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