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

NCT ID: NCT06075004

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2025-10-23

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.

Detailed Description

Patients who agree to participate in the protocol will be assigned to one group or another (PAI or posterior PAI+PENGB) through computationally generated block randomization. Outcome assessors blinded to randomization will perform all measurements.

All trial interventions (PAI or posterior PAI+PENGB) will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon anesthesiologist. Both interventions will be executed in the operating room, on the surgical table, under sedation, and with the barrier that separates the surgical field from the cranial area of the patient to keep the latter blind to the technique received.

All patients will undergo spinal anesthesia using 0.5% bupivacaine (10mg) plus 20 μg of fentanyl. Both groups will also receive tranexamic acid 1g intravenous (IV), ketoprofen 100mg IV, and acetaminophen 1gr IV. Propofol sedation guided with a targeted controlled infusion (TCI) model will be administered in order to obtain an adequate level of sedation.

All surgeries will be conducted by the same team of surgeons, performing a posterior approach technique in the lateral decubitus position.

In the recovery room, all patients will receive patient-controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (1 g per os every 6 hours), ketoprofen (100 mg per os every 8 hours) as well and patient-controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

Conditions

Hip Osteoarthritis; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Periarticular Local Anesthetic Infiltration

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.

Group Type: ACTIVE_COMPARATOR

Periarticular Local Anesthetic Infiltration

Intervention Type: 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.

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

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.

Group Type: EXPERIMENTAL

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

Intervention Type: 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.

Interventions

Periarticular Local Anesthetic Infiltration

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.

Intervention Type: PROCEDURE

Posterior Periarticular Local Anesthetic Infiltration plus Pericapsular Nerve Group Block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 ≤ 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Daniela Bravo Advis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Bravo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Daniela Bravo, MD

Role: CONTACT

dbravoadvis@uchile.cl

569222878209

Facility Contacts

Daniela B Advis

Role: primary

dbravoadvis@uchile.cl

+56984276252

References

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.

Reference Type: BACKGROUND

PMID: 17403800 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31663402 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30063657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28850408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36948525 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37028817 (View on PubMed)

Other Identifiers

OAIC 1379/23

Identifier Type: -

Identifier Source: org_study_id