Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain; Motor Activity; Weakness, Muscle
• Intervention / Treatment: Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block; Procedure: Ultrasound-guided pericapsular nerves group of the hip block

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitan
    • Santiago, Metropolitan, Chile, 8380456
      • Hospital Clinico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: suprainguinal fascia iliaca block; 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.	Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block; 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.
Experimental: Pericapsular nerve group block; 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.	Procedure: Ultrasound-guided pericapsular nerves group of the hip block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 hours after block performance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block performance time	temporal interval between the start of skin disinfection and the end of LA injection through the block needle	1 hour after surgery
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)	3 hours after the block
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)	6 hours after the block
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)	12 hours after the block
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)	18 hours after the block
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)	24 hours after the block
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)	36 hours after the block
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)	48 hours after the block
Postoperative morphine consumption	consumption of intravenous morphine registered by a patient controlled analgesia device	24 hours after the block
Postoperative morphine consumption	consumption of intravenous morphine registered by a patient controlled analgesia device	48 hours after the block
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)	3 hours after the block
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)	6 hours after the block
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)	24 hours after the block
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).	3 hours after the block
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).	24 hours after the block
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.	3 hours after the block
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.	6 hours after the block
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.	24 hours after the block
Block-related complications	vascular puncture, paresthesia or systemic local anesthetic toxicity	1 hour after the block
Postoperative opioid related side effects	Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression	48 hours after the block
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.	Postoperative day 1
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.	postoperative day 2
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.	postoperative day 1
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.	postoperative day 2

Collaborators and Investigators

• Sponsor: University of Chile

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Postoperative Complications
• Other Study ID Numbers: OAIC 1111/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: unidentified data can be shared upon reasonable request after study publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No