NCT05898581

Brief Summary

Currently, the analgesic standard of care for patients undergoing total hip arthroplasty (THA) at our centre is intraoperative infiltration with a solution of local anesthetic, morphine (opioid), and ketorolac (nonsteroidal anti-inflammatory drug - NSAID). If a patient has a contraindication for the use of an opioid or NSAIDs, this infiltration is performed with a plain local anesthetic. No blocks (numbing of certain nerves to prevent pain from occurring in that area) are performed for postoperative pain in these patients. The pericapsular nerve group (PENG) block is a recently described technique with limited data in the literature that has assessed the benefits of using this nerve block for THA procedures. The purpose of this study is to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration (ILAI) with an associated cost benefit for patients undergoing THA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2024Jul 2026

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

June 2, 2023

Last Update Submit

September 12, 2025

Conditions

Keywords

anesthesiatotal hip arthroplastyPericapsular Nerve Group Block

Outcome Measures

Primary Outcomes (1)

  • PENG block impact on post-operative pain scores

    Patient pain scores will be evaluated at 8 hours and 24 hours following completion of spinal anesthesia to determine the impact of the PENG block on post-operative pain. Pain scores will be assessed using a Likert scale rating (0-10, 0 = no pain, 10 = sever, disabling pain).

    8-24 hours following completion of spinal anesthesia

Secondary Outcomes (3)

  • PENG block impact on quadriceps muscle strength post-operatively

    8-24 hours following completion of spinal anesthesia

  • Time spent in post-anesthesia care unit (PACU) following surgery

    Up to 24 hours following completion of spinal anesthesia.

  • Patient opioid consumption 24 hours period after spinal anesthesia procedure.

    24 hours following following completion of spinal anesthesia.

Study Arms (2)

PENG Block

EXPERIMENTAL

Participants will receive ultrasound-guided PENG block (PENG group) with local anesthetics (20 ml of 0.5% ropivacaine) before administration of spinal anesthesia. Patients in this group will also receive a sham ILAI procedure with 60 mL of saline (performed by the operating surgeon).

Procedure: PENG Block

Control Group

SHAM COMPARATOR

Participants will receive a sham PENG block performed with 20ml of normal saline solution before spinal anesthesia. After, patients will receive ILAI (performed by the operating surgeon) with a plain solution of ropivacaine 0.25% 60ml.

Procedure: Control Group

Interventions

PENG BlockPROCEDURE

Participants will receive a PENG block with local anesthetics (which is a freezing medication, in this case, 0.5% ropivacaine) before receiving spinal anesthesia. Patients in this group will also receive a sham ILAI procedure with 60 mL of saline (performed by the operating surgeon).

PENG Block
Control GroupPROCEDURE

Participants will receive a sham PENG block performed with 20ml of normal saline solution before spinal anesthesia. After, patients will receive ILAI (performed by the operating surgeon) with a plain solution of ropivacaine 0.25% 60ml.

Control Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (\>18 years old)
  • Undergoing THA with a direct lateral surgical approach (transgluteal approach)
  • Ability to provide verbal/written consent to participate in this trial

You may not qualify if:

  • Patient with any contraindication for spinal anesthesia
  • Patient with any contraindication for regional analgesia
  • Patient undergoing THA with a direct anterior surgical approach
  • Patients undergoing THA for hip revision
  • Patients undergoing THA under One Day Stay (ODS) admission
  • Patients that received opioids intrathecally
  • Patients having residual motor block six hours after the completion of the spinal anesthesia.
  • Patients with a history of regular opioid intake for more than three months
  • Patients incapable of performing knee extension of the same operative side
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Related Publications (19)

  • Behrends M, Yap EN, Zhang AL, Kolodzie K, Kinjo S, Harbell MW, Aleshi P. Preoperative Fascia Iliaca Block Does Not Improve Analgesia after Arthroscopic Hip Surgery, but Causes Quadriceps Muscles Weakness: A Randomized, Double-blind Trial. Anesthesiology. 2018 Sep;129(3):536-543. doi: 10.1097/ALN.0000000000002321.

    PMID: 29975203BACKGROUND
  • Xing JG, Abdallah FW, Brull R, Oldfield S, Dold A, Murnaghan ML, Whelan DB. Preoperative Femoral Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2680-7. doi: 10.1177/0363546515602468. Epub 2015 Sep 24.

    PMID: 26403206BACKGROUND
  • Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

    PMID: 29140962BACKGROUND
  • 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: 30063657BACKGROUND
  • Ban WR, Zhang EA, Lv LF, Dang XQ, Zhang C. Effects of periarticular injection on analgesic effects and NSAID use in total knee arthroplasty and total hip arthroplasty. Clinics (Sao Paulo). 2017 Dec;72(12):729-736. doi: 10.6061/clinics/2017(12)03.

    PMID: 29319718BACKGROUND
  • Villatte G, Engels E, Erivan R, Mulliez A, Caumon N, Boisgard S, Descamps S. Effect of local anaesthetic wound infiltration on acute pain and bleeding after primary total hip arthroplasty: the EDIPO randomised controlled study. Int Orthop. 2016 Nov;40(11):2255-2260. doi: 10.1007/s00264-016-3133-3. Epub 2016 Feb 22.

    PMID: 26899484BACKGROUND
  • Murphy TP, Byrne DP, Curtin P, Baker JF, Mulhall KJ. Can a periarticular levobupivacaine injection reduce postoperative opiate consumption during primary hip arthroplasty? Clin Orthop Relat Res. 2012 Apr;470(4):1151-7. doi: 10.1007/s11999-011-2108-3. Epub 2011 Sep 30.

    PMID: 21960156BACKGROUND
  • Liu W, Cong R, Li X, Wu Y, Wu H. Reduced opioid consumption and improved early rehabilitation with local and intraarticular cocktail analgesic injection in total hip arthroplasty: a randomized controlled clinical trial. Pain Med. 2011 Mar;12(3):387-93. doi: 10.1111/j.1526-4637.2010.01043.x. Epub 2011 Jan 25.

    PMID: 21266004BACKGROUND
  • Busch CA, Whitehouse MR, Shore BJ, MacDonald SJ, McCalden RW, Bourne RB. The efficacy of periarticular multimodal drug infiltration in total hip arthroplasty. Clin Orthop Relat Res. 2010 Aug;468(8):2152-9. doi: 10.1007/s11999-009-1198-7. Epub 2009 Dec 18.

    PMID: 20020333BACKGROUND
  • Hofstad JK, Winther SB, Rian T, Foss OA, Husby OS, Wik TS. Perioperative local infiltration anesthesia with ropivacaine has no effect on postoperative pain after total hip arthroplasty. Acta Orthop. 2015;86(6):654-8. doi: 10.3109/17453674.2015.1053775. Epub 2015 May 22.

    PMID: 25997827BACKGROUND
  • den Hartog YM, Mathijssen NM, van Dasselaar NT, Langendijk PN, Vehmeijer SB. No effect of the infiltration of local anaesthetic for total hip arthroplasty using an anterior approach: a randomised placebo controlled trial. Bone Joint J. 2015 Jun;97-B(6):734-40. doi: 10.1302/0301-620X.97B6.35343.

    PMID: 26033051BACKGROUND
  • Zoric L, Cuvillon P, Alonso S, Demattei C, Vialles N, Asencio G, Ripart J, Nouvellon E. Single-shot intraoperative local anaesthetic infiltration does not reduce morphine consumption after total hip arthroplasty: a double-blinded placebo-controlled randomized study. Br J Anaesth. 2014 Apr;112(4):722-8. doi: 10.1093/bja/aet439. Epub 2014 Jan 14.

    PMID: 24431385BACKGROUND
  • Lunn TH, Husted H, Solgaard S, Kristensen BB, Otte KS, Kjersgaard AG, Gaarn-Larsen L, Kehlet H. Intraoperative local infiltration analgesia for early analgesia after total hip arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):424-9. doi: 10.1097/AAP.0b013e3182186866.

    PMID: 21610559BACKGROUND
  • Hirasawa N, Kurosaka K, Nishino M, Nakayama T, Matsubara M, Tsukada S. No Clinically Important Difference in Pain Scores After THA Between Periarticular Analgesic Injection and Placebo: A Randomized Trial. Clin Orthop Relat Res. 2018 Sep;476(9):1837-1845. doi: 10.1097/CORR.0000000000000374.

    PMID: 29939894BACKGROUND
  • Dobie I, Bennett D, Spence DJ, Murray JM, Beverland DE. Periarticular local anesthesia does not improve pain or mobility after THA. Clin Orthop Relat Res. 2012 Jul;470(7):1958-65. doi: 10.1007/s11999-012-2241-7. Epub 2012 Jan 24.

    PMID: 22270468BACKGROUND
  • Kukreja P, Avila A, Northern T, Dangle J, Kolli S, Kalagara H. A Retrospective Case Series of Pericapsular Nerve Group (PENG) Block for Primary Versus Revision Total Hip Arthroplasty Analgesia. Cureus. 2020 May 19;12(5):e8200. doi: 10.7759/cureus.8200.

    PMID: 32572357BACKGROUND
  • 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.

    PMID: 34290085BACKGROUND
  • Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.

    PMID: 35933328BACKGROUND
  • Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

    PMID: 34873023BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Shalini Dhir, FRCPC

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Araujo Monteiro da Silva, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be a single-centre, double-blinded non-inferiority randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Associate Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

November 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations