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Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

Primary Purpose

Postoperative Complications, Postoperative Pain, Weakness, Muscle

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Ultrasound-guided suprainguinal fascia iliaca nerve block
Ultrasound-guided pericapsular nerves group of the hip block
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50)
  • Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • Allergy to local anesthetics (LAs)
  • Pregnancy
  • Prior surgery in the corresponding side of the inguinal or suprainguinal area
  • Chronic pain syndromes requiring opioid intake at home

Sites / Locations

  • Hospital Clínico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

suprainguinal fascia iliaca block

Pericapsular nerve group block

Arm Description

Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.

Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle.

Outcomes

Primary Outcome Measures

Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

Secondary Outcome Measures

Block performance time
temporal interval between the start of skin disinfection and the end of LA injection through the block needle
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Postoperative morphine consumption
consumption of intravenous morphine registered by a patient controlled analgesia device
Postoperative morphine consumption
consumption of intravenous morphine registered by a patient controlled analgesia device
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Block-related complications
vascular puncture, paresthesia or systemic local anesthetic toxicity
Postoperative opioid related side effects
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.

Full Information

First Posted
May 13, 2020
Last Updated
September 26, 2021
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04402450
Brief Title
Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia
Official Title
A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

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

5. Study Description

Brief Summary
In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Pain, Weakness, Muscle, Motor Activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized comparison between two analgesic techniques
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suprainguinal fascia iliaca block
Arm Type
Active Comparator
Arm Description
Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
Arm Title
Pericapsular nerve group block
Arm Type
Experimental
Arm Description
Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided suprainguinal fascia iliaca nerve block
Intervention Description
After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided pericapsular nerves group of the hip block
Intervention Description
After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.
Primary Outcome Measure Information:
Title
Presence of quadriceps motor block (defined as paralysis or paresis).
Description
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
6 hours after block performance
Secondary Outcome Measure Information:
Title
Block performance time
Description
temporal interval between the start of skin disinfection and the end of LA injection through the block needle
Time Frame
1 hour after surgery
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
3 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
6 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
12 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
18 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
24 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
36 hours after the block
Title
Static and dynamic pain
Description
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Time Frame
48 hours after the block
Title
Postoperative morphine consumption
Description
consumption of intravenous morphine registered by a patient controlled analgesia device
Time Frame
24 hours after the block
Title
Postoperative morphine consumption
Description
consumption of intravenous morphine registered by a patient controlled analgesia device
Time Frame
48 hours after the block
Title
Sensory block
Description
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Time Frame
3 hours after the block
Title
Sensory block
Description
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Time Frame
6 hours after the block
Title
Sensory block
Description
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Time Frame
24 hours after the block
Title
Presence of quadriceps motor block (defined as paralysis or paresis).
Description
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
3 hours after the block
Title
Presence of quadriceps motor block (defined as paralysis or paresis).
Description
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Time Frame
24 hours after the block
Title
Hip adduction strength.
Description
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Time Frame
3 hours after the block
Title
Hip adduction strength.
Description
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Time Frame
6 hours after the block
Title
Hip adduction strength.
Description
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Time Frame
24 hours after the block
Title
Block-related complications
Description
vascular puncture, paresthesia or systemic local anesthetic toxicity
Time Frame
1 hour after the block
Title
Postoperative opioid related side effects
Description
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Time Frame
48 hours after the block
Title
Inability to perform physiotherapy due to motor block
Description
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.
Time Frame
Postoperative day 1
Title
Inability to perform physiotherapy due to motor block
Description
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.
Time Frame
postoperative day 2
Title
Inability to perform physiotherapy due to pain
Description
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.
Time Frame
postoperative day 1
Title
Inability to perform physiotherapy due to pain
Description
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.
Time Frame
postoperative day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years American Society of Anesthesiologists classification 1-3 Body mass index between 20 and 35 (kg/m2) Exclusion Criteria: Adults who are unable to give their own consent Pre-existing neuropathy (assessed by history and physical examination) Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50) Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) Allergy to local anesthetics (LAs) Pregnancy Prior surgery in the corresponding side of the inguinal or suprainguinal area Chronic pain syndromes requiring opioid intake at home
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitan
ZIP/Postal Code
8380456
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
unidentified data can be shared upon reasonable request after study publication
Citations:
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
result
PubMed Identifier
21401544
Citation
Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
Results Reference
result
PubMed Identifier
34290085
Citation
Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
Results Reference
derived

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Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

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