Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty

NCT06317870 | Recruiting DMC

• 1 other identifier: CHUV_PENGIT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain. Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding.

Conditions

Analgesia; Hip Arthropathy; Post Operative Pain

Keywords

nerve block; intrathecal morphine; postoperative pain; hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative postoperative morphine consumption at day 1

  total consumption in mg

  24 hours postoperatively

Secondary Outcomes (9)

• Morphine consumption in the recovery room

  from admission till discharge from the recovery room, up to 2 hours

• PCA administered morphine consumption at day 2

  at day 2 postoperatively

• rest and dynamic pain scores

  at 2 hours, day 1 and day 2 postoperatively

• Incidence of postoperative nausea and vomiting

  at 2 hours, day 1 and day 2 postoperatively

• Incidence of pruritus

  at 2 hours, day 1 and day 2 postoperatively

Study Arms (2)

PENG group

EXPERIMENTAL

Pericapsular nerve group block

Procedure: Pericapsular nerve group block (PENG)

ITM group

ACTIVE COMPARATOR

intrathecal morphine injection

Procedure: Intrathecal morphine

Interventions

Intrathecal morphine PROCEDURE

Spinal anesthesia will be performed as follows: patient will be placed in the lateral decubitus position on the non-operative side. Using sterile gloves red chlorhexidine 2% alcohol solution will be used for skin disinfection. The site will be secured with a sterile drape, and the L4-L5 lumbar space identified. After subcutaneous local infiltration with 1% lidocaine, a 25G Whitacre pencil point spinal needle will be used to access the intrathecal space with free flow of cerebrospinal fluid as confirmation. A mixture of 12.5 mg of isobaric bupivacaine and 100 mcg of morphine will be administered intrathecally. After the spinal anesthesia, the intrathecal morphine (ITM) group will receive a sham PENG block with the block needle inserted subcutaneously, the anesthesiologist using the same verbal block confirmation commands "aspirate, inject" but the needle withdrawn without injection. This will create the appearance of an identical cutaneous injection site to ensure patient blinding.

ITM group

Pericapsular nerve group block (PENG) PROCEDURE

Spinal anesthesia with intrathecal injection of 12.5 mg of isobaric bupivacaine will be performed, followed by a PENG block. After skin disinfection, a low frequency curvilinear ultrasound probe (2-5 MHz 8870, BK ultrasound, Peabody Massachussets, US) with a sterile covering will be used to identify the anterior inferior iliac spine, the pubic eminence and the psoas tendon with its fascial plane. A 22 gauge 10cm block needle (Sonoplex® Pajunk, Geisingen, DE), will be used to enter the fascial plane and 20ml of 0.75% Ropivacain (Fresenius Kabi, Krienz CH) will be injected.

PENG group

Eligibility Criteria

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

You may qualify if:

• Male and female patients
• ASA (American Society of Anaesthesiologists) I-III
• years of age or older
• Patients scheduled for elective primary hip arthroplasty
• Able to give written conformed consent autonomously

You may not qualify if:

• Refusal or inability to give consent
• Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
• Bleeding diathesis
• Neurological deficit of the operative side
• Existing preoperative opioid use
• Renal insufficiency (GFR\<30ml/min according to the Cockroft-Gault formula)
• Hepatic insufficiency
• Pregnant or lactating women

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (12)

• Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.

  PMID: 34015859 BACKGROUND

• Gonvers E, El-Boghdadly K, Grape S, Albrecht E. Efficacy and safety of intrathecal morphine for analgesia after lower joint arthroplasty: a systematic review and meta-analysis with meta-regression and trial sequential analysis. Anaesthesia. 2021 Dec;76(12):1648-1658. doi: 10.1111/anae.15569. Epub 2021 Aug 27.

  PMID: 34448492 BACKGROUND

• Vitola E, Buraka N, Erts R, Golubovska I, Miscuks A. Effect of different low doses of intrathecal morphine (0.1 and 0.2 mg) on pain and vital functions in patients undergoing total hip arthroplasty: a randomised controlled study. BMC Anesthesiol. 2022 Dec 5;22(1):377. doi: 10.1186/s12871-022-01919-8.

  PMID: 36471258 BACKGROUND

• Kuchalik J, Granath B, Ljunggren A, Magnuson A, Lundin A, Gupta A. Postoperative pain relief after total hip arthroplasty: a randomized, double-blind comparison between intrathecal morphine and local infiltration analgesia. Br J Anaesth. 2013 Nov;111(5):793-9. doi: 10.1093/bja/aet248. Epub 2013 Jul 19.

  PMID: 23872462 BACKGROUND

• Souron V, Delaunay L, Schifrine P. Intrathecal morphine provides better postoperative analgesia than psoas compartment block after primary hip arthroplasty. Can J Anaesth. 2003 Jun-Jul;50(6):574-9. doi: 10.1007/BF03018643.

  PMID: 12826549 BACKGROUND

• Kearns R, Macfarlane A, Grant A, Puxty K, Harrison P, Shaw M, Anderson K, Kinsella J. A randomised, controlled, double blind, non-inferiority trial of ultrasound-guided fascia iliaca block vs. spinal morphine for analgesia after primary hip arthroplasty. Anaesthesia. 2016 Dec;71(12):1431-1440. doi: 10.1111/anae.13620. Epub 2016 Oct 7.

  PMID: 27714758 BACKGROUND

• Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.

  PMID: 33370462 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

• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

  PMID: 34196965 BACKGROUND

• 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: 35933328 BACKGROUND

• Hu J, Wang Q, Hu J, Kang P, Yang J. Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Combined With Local Infiltration Analgesia on Postoperative Pain After Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2023 Jun;38(6):1096-1103. doi: 10.1016/j.arth.2022.12.023. Epub 2022 Dec 16.

  PMID: 36529195 BACKGROUND

• 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: 34290085 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Eric Albrecht, Prof

CONTACT

+41795566341; eric.albrecht@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med. Eric Albrecht, Associate Professor, University of Lausanne

Model Details: single centered, prospective, double blinded non inferiority trial

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)