PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

NCT05308420 | Completed Phase 4

• 1 other identifier: 022021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.

Conditions

Total Hip Arthroplasty; Postoperative Pain

Keywords

Total hip arthroplasty; Postoperative pain; Anesthesia, Regional

Outcome Measures

Primary Outcomes (3)

• Maximum pain at rest

  maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes

  48 postoperative hours

• Maximum pain with active hip flexion

  maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes

  48 postoperative hours

• cumulative morphine equivalent dose over 48 post-operative hours

  cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes

  48 postoperative hours

Secondary Outcomes (2)

• Quadriceps muscle motor block

  24 postoperative hours

• Opioid side effects

  48 postoperative hours

Study Arms (2)

PENG block

ACTIVE COMPARATOR

Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone

Procedure: Pericapsular nerve group (PENG) block; Procedure: Spinal anesthesia; Drug: Intrathecal placebo

Intrathecal morphine

ACTIVE COMPARATOR

Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone.

Procedure: Spinal anesthesia; Drug: Intrathecal morphine; Procedure: Sham PENG block

Interventions

Pericapsular nerve group (PENG) block PROCEDURE

A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule

PENG block

Spinal anesthesia PROCEDURE

Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally

Intrathecal morphine; PENG block

Intrathecal morphine DRUG

100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)

Intrathecal morphine

Sham PENG block PROCEDURE

A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule

Intrathecal morphine

Intrathecal placebo DRUG

0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)

PENG block

Eligibility Criteria

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

You may qualify if:

• adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent

You may not qualify if:

• patient unwilling / unable to provide informed consent
• contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
• high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
• preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
• pregnancy
• substance abuse
• change of surgical plan
• violation of study protocol

Sponsors & Collaborators

• Kresimir Oremus, MD: lead

Study Sites (1)

Akromion Special Hospital for Orthopedic Surgery

Krapinske Toplice, 49217, Croatia

Location

Related Publications (4)

• 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

• Hess SR, Lahaye LA, Waligora AC, Sima AP, Jiranek WA, Golladay GJ. Safety and side-effect profile of intrathecal morphine in a diverse patient population undergoing total knee and hip arthroplasty. Eur J Orthop Surg Traumatol. 2019 Jan;29(1):125-129. doi: 10.1007/s00590-018-2293-9. Epub 2018 Aug 13.

  PMID: 30105593 BACKGROUND

• 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

• Oremus K, Trkulja V, Gasparini G, Sostaric S, Cicak N, Haspl M, Mihaljevic S. Pericapsular nerve group (PENG) block compared to intrathecal morphine for analgesic efficacy in total hip arthroplasty: A placebo-controlled randomized double-blind non-inferiority trial. J Clin Anesth. 2025 Sep;106:111921. doi: 10.1016/j.jclinane.2025.111921. Epub 2025 Jul 2.

  PMID: 40609218 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered. Outcome assessor/statistician will be blinded as to which group received which intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Division of Anesthesiology

Model Details: Non-inferiority randomized triple-blinded controlled trial

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 4, 2022
• Study Start: April 3, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)