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Clinical Trials/NCT04402450
NCT04402450
Completed
Not Applicable

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

University of Chile1 site in 1 country40 target enrollmentAugust 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
University of Chile
Enrollment
40
Locations
1
Primary Endpoint
Presence of quadriceps motor block (defined as paralysis or paresis).
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2020
End Date
May 28, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Principal Investigator
Principal Investigator

Julian Aliste

Assistant Professor

University of Chile

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

Outcomes

Primary Outcomes

Presence of quadriceps motor block (defined as paralysis or paresis).

Time Frame: 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 Outcomes

  • Inability to perform physiotherapy due to motor block(postoperative day 2)
  • Presence of quadriceps motor block (defined as paralysis or paresis).(24 hours after the block)
  • Postoperative opioid related side effects(48 hours after the block)
  • Inability to perform physiotherapy due to pain(postoperative day 2)
  • Static and dynamic pain(48 hours after the block)
  • Postoperative morphine consumption(48 hours after the block)
  • Block-related complications(1 hour after the block)
  • Block performance time(1 hour after surgery)
  • Sensory block(24 hours after the block)
  • Hip adduction strength.(24 hours after the block)

Study Sites (1)

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