Total Periarticular Infiltration Vs Posterior Periarticular Infiltration Plus PENG Block for Hip Analgesia

NCT06075004 | Recruiting DMC

• 1 other identifier: OAIC 1379/23
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

In a recent study, direct periarticular local anesthetic infiltration (PAI) showed a greater incidence of early quadriceps weakness (33% at 3 hours and 13% at 6 hours) than pericapsular nerve group block (PENGB) in total hip arthroplasty (THA) but, in turn, demonstrated a statistically significant better pain control. Additionally, PENGB could not completely circumvent motor compromise either, particularly at 3 hours (20% incidence), probably secondary to an injectate migration towards the femoral nerve. Posteriorly to this publication, a cadaveric trial looking into the maximum effective volume that spared the femoral nerve resulted in 13.2 mL. This newer evidence led to the design of a strategy that combines both interventions, aiming to obtain the best of them and have a solid alternative for those cases where very early mobilization is pursued. Thus, it is hypothesized that posterior PAI added to a low-volume PENGB (10mL) represents a superior alternative to PAI in terms of strength preservation and provides effective analgesia during the first 24 postoperative hours after THA.

Conditions

Hip Osteoarthritis; Postoperative Pain

Keywords

Nerve block; Periarticular infiltration; Hip replacement; Early rehabilitation

Outcome Measures

Primary Outcomes (1)

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

  Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. 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 post anesthesia care unit (PACU) arrival

Secondary Outcomes (28)

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

  6 hours after post anesthesia care unit (PACU) arrival

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

  24 hours after post anesthesia care unit (PACU) arrival

• Hip adduction strength

  3 hours after post anesthesia care unit (PACU) arrival

• Hip adduction strength

  6 hours after post anesthesia care unit (PACU) arrival

• Hip adduction strength

  24 hours after post anesthesia care unit (PACU) arrival

Study Arms (2)

Periarticular Local Anesthetic Infiltration

ACTIVE COMPARATOR

60 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the periarticular level before wound closure.

Procedure: Periarticular Local Anesthetic Infiltration

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

EXPERIMENTAL

45 mL of 0.25% bupivacaine with 5ug/mL epinephrine will be deposited under direct vision during surgery at the posterior periarticular level before wound closure. After wound closure, an ultrasound-guided pericapsular nerve group block of the hip will be performed using ten mL of 0.5% bupivacaine with 5ug/mL epinephrine.

Procedure: Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

Interventions

Periarticular Local Anesthetic Infiltration PROCEDURE

Sixty milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg will be deposited by the orthopedic surgeon at the periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure.

Periarticular Local Anesthetic Infiltration

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block PROCEDURE

From a total of forty-five milliliters of 0.25% bupivacaine + 5ug/mL epinephrine and ketorolac 30 mg, 15mL will be deposited by the orthopedic surgeon at the posterior periarticular level under direct vision during surgery. Fascia, subcutaneous tissues, and skin will also be infiltrated with part of the solution before wound closure with the remaining 30mL. After wound closure, an ultrasound-guided pericapsular nerve group block will be performed by an anesthesiologist by injecting 10mL of 0.5% bupivacaine + 5ug/mL epinephrine in the plane between the iliac bone periosteum and the tendon of the iliopsoas muscle.

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 ≤ 100, International Normalized Ratio ≥ 1.4 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) or morphine
• Pregnancy
• Prior surgery in the inguinal area corresponding surgical side
• Chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

RECRUITING

Related Publications (6)

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.

  PMID: 31663402 BACKGROUND

• 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.

  PMID: 30063657 BACKGROUND

• Kuchalik J, Magnuson A, Lundin A, Gupta A. Local infiltration analgesia or femoral nerve block for postoperative pain management in patients undergoing total hip arthroplasty. A randomized, double-blind study. Scand J Pain. 2017 Jul;16:223-230. doi: 10.1016/j.sjpain.2017.05.002. Epub 2017 Jun 1.

  PMID: 28850408 BACKGROUND

• Bravo D, Aliste J, Layera S, Fernandez D, Erpel H, Aguilera G, Arancibia H, Barrientos C, Wulf R, Leon S, Branes J, Finlayson RJ, Tran Q. Randomized clinical trial comparing pericapsular nerve group (PENG) block and periarticular local anesthetic infiltration for total hip arthroplasty. Reg Anesth Pain Med. 2023 Oct;48(10):520-521. doi: 10.1136/rapm-2023-104487. Epub 2023 Mar 22. No abstract available.

  PMID: 36948525 BACKGROUND

• Leurcharusmee P, Kantakam P, Intasuwan P, Malatong Y, Maikong N, Navic P, Kitcharanant N, Mahakkanukrauh P, Tran Q. Cadaveric study investigating the femoral nerve-sparing volume for pericapsular nerve group (PENG) block. Reg Anesth Pain Med. 2023 Nov;48(11):549-552. doi: 10.1136/rapm-2023-104419. Epub 2023 Apr 7.

  PMID: 37028817 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Daniela Bravo, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Bravo, MD

CONTACT

569222878209; dbravoadvis@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized comparison between two analgesic techniques

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 18, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 23, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)