Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

Not Applicable

Completed

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

• Registration Number: NCT04402450
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-26
• Study Start: 2020-08-31
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suprainguinal fascia iliaca block	Ultrasound-guided suprainguinal fascia iliaca nerve 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.
Pericapsular nerve group block	Ultrasound-guided pericapsular nerves group of the hip 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.

Primary Outcome Measures

Name	Time	Method
Presence of quadriceps motor block (defined as paralysis or paresis).	6 hours after block performance	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

Name	Time	Method
Inability to perform physiotherapy due to motor block	postoperative day 2	Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.
Presence of quadriceps motor block (defined as paralysis or paresis).	24 hours after the block	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).
Postoperative opioid related side effects	48 hours after the block	Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Inability to perform physiotherapy due to pain	postoperative day 2	Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.
Static and dynamic pain	48 hours after the block	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	48 hours after the block	consumption of intravenous morphine registered by a patient controlled analgesia device
Block-related complications	1 hour after the block	vascular puncture, paresthesia or systemic local anesthetic toxicity
Block performance time	1 hour after surgery	temporal interval between the start of skin disinfection and the end of LA injection through the block needle
Sensory block	24 hours after the 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)
Hip adduction strength.	24 hours after the block	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.

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitan, Chile