Low-Volume PENG Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty

NCT07855341 | Not Yet Recruiting Phase 4

• 1 other identifier: FMASU MD232/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral total hip arthroplasty under spinal anaesthesia. The PENG block was originally proposed as a motor-sparing technique. However, the standard 20 mL volume can spread to the femoral nerve and cause quadriceps weakness. Reducing the injected volume may limit this spread and better preserve quadriceps strength, but smaller volumes risk shorter analgesic duration. Adding dexamethasone to a low-volume injection may compensate for the reduced volume. The main questions this trial aims to answer are:

• Does a low-volume PENG block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone differ from a standard-volume PENG block (20 mL bupivacaine 0.25%) in the time to first rescue analgesia?
• Does it differ in the incidence and severity of quadriceps weakness on the operated side? Researchers will compare:
• Group A (standard-volume PENG block): 20 mL bupivacaine 0.25%.
• Group B (low-volume PENG block with dexamethasone): 5 mL bupivacaine 0.5% plus 4 mL normal saline plus 4 mg dexamethasone in 1 mL, giving 10 mL of bupivacaine 0.25%. Participants will:
• Receive spinal anaesthesia with heavy bupivacaine 0.5% and fentanyl.
• Be randomly allocated to Group A or Group B using computer-generated random numbers.
• Receive the PENG block under ultrasound guidance, performed by an anaesthesiologist expert in regional anaesthesia.
• Receive intravenous paracetamol 1 g every 8 hours, with intravenous nalbuphine 5 mg as rescue analgesia when the pain score (NRS) is 4 or more.
• Be assessed by an anaesthesiologist blinded to group allocation for pain scores at rest and on movement at 2, 6, 12 and 24 hours; quadriceps strength (MRC scale and straight leg raise) at 6, 12 and 24 hours compared with the preoperative baseline; total opioid consumption over the first 24 hours; and time to first ambulation within the first 24 hours. The primary outcome is the time from completion of the PENG block to the first administration of rescue analgesia, recorded over the first 24 hours postoperatively. The study will be conducted at Ain Shams University Hospitals (El Demerdash Hospital) and will include 60 patients (30 per group), aged 50 to 70 years, ASA physical status I or II.

Conditions

Pain, Postoperative; Muscle Weakness; Arthroplasty, Replacement, Hip

Keywords

PENG block; Pericapsular Nerve Group Block; Dexamethasone; Bupivacaine; Quadriceps Strength; Total Hip Arthroplasty; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Time to First Rescue Analgesia

  The interval (in hours) from completion of the PENG block to the first administration of rescue analgesia (intravenous nalbuphine 5 mg, given when the Numerical Rating Scale pain score is 4 or more on a 0-10 scale, where 0 = no pain and 10 = worst possible pain).

  From completion of the PENG block up to 24 hours postoperatively

Secondary Outcomes (3)

• Incidence and Severity of Quadriceps Weakness

  Preoperative baseline and at 6, 12 and 24 hours postoperatively

• Total Opioid Consumption

  First 24 hours postoperatively

• Time to First Ambulation

  Within the first 24 hours postoperatively

Study Arms (2)

Group B: Low-Volume PENG Block With Dexamethasone

EXPERIMENTAL

Patients will receive an ultrasound-guided PENG block with 5 mL of bupivacaine 0.5% (25 mg) plus 4 mL of normal saline plus 4 mg dexamethasone in 1 mL, giving a total injectate volume of 10 mL of bupivacaine 0.25%, after spinal anaesthesia.

Procedure: Pericapsular nerve group (PENG) block; Drug: Bupivacaine; Drug: Dexamethasone

Group A: Standard-Volume PENG Block

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided PENG block with 20 mL of bupivacaine 0.25% (50 mg) after spinal anaesthesia.

Procedure: Pericapsular nerve group (PENG) block; Drug: Bupivacaine

Interventions

Pericapsular nerve group (PENG) block PROCEDURE

An 80-100 mm, 22-gauge echogenic needle is advanced in-plane from lateral to medial into the plane between the psoas tendon and the iliopubic eminence under ultrasound guidance using a low-frequency curvilinear transducer (2-5 MHz), and the local anaesthetic is injected in increments after negative aspiration. Correct injectate spread deep to the psoas tendon will be confirmed sonographically.

Also known as: PENG block

Group A: Standard-Volume PENG Block; Group B: Low-Volume PENG Block With Dexamethasone

Bupivacaine DRUG

Group A: 20 mL of bupivacaine 0.25% (50 mg). Group B: 5 mL of bupivacaine 0.5% (25 mg) diluted to a total injectate volume of 10 mL of bupivacaine 0.25%. Injected as the PENG block.

Also known as: Marcaine

Group A: Standard-Volume PENG Block; Group B: Low-Volume PENG Block With Dexamethasone

Dexamethasone DRUG

4 mg dexamethasone in 1 mL added to the PENG block injectate in Group B (perineural).

Also known as: Decadron

Group B: Low-Volume PENG Block With Dexamethasone

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status ASA I or II.
• Age 50-70 years.
• Patients scheduled for elective primary unilateral total hip arthroplasty under spinal anaesthesia.
• No sex predilection.

You may not qualify if:

• Patient refusal.
• Physical status ASA III or above.
• Contraindications to spinal anaesthesia (coagulopathy, local infection at injection site, raised intracranial pressure).
• Revision or bilateral total hip arthroplasty.
• Known allergy or hypersensitivity to study drugs (bupivacaine, dexamethasone) or to any component of the multimodal analgesic regimen (paracetamol, nalbuphine).
• Pre-existing neuromuscular disease, lower-limb motor deficit, or neuropathic pain syndrome.
• Uncontrolled diabetes mellitus (HbA1c \> 8% or fasting blood glucose \> 180 mg/dL) or any contraindication to corticosteroids.
• Cognitive impairment precluding pain and motor assessment, or chronic opioid use.
• Body mass index greater than 40 kg/m2 precluding adequate ultrasound visualization.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals (El Demerdash Hospital)

Cairo, Cairo Governorate, 00202, Egypt

Location

Related Publications (10)

• Yu L, Shen X, Liu H. The efficacy of pericapsular nerve group block for postoperative analgesia in patients undergoing hip surgery: A systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2023 Feb 24;10:1084532. doi: 10.3389/fmed.2023.1084532. eCollection 2023.

  PMID: 36910500 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

• Balasubramaniam A, Kumar Naggaih S, Tarigonda S, Madhusudhana R. Ultrasound-Guided Pericapsular Nerve Group Block for Hip Surgery: A Randomized Controlled Trial Study Comparing Ropivacaine and Ropivacaine With Dexamethasone. Cureus. 2023 Jan 27;15(1):e34261. doi: 10.7759/cureus.34261. eCollection 2023 Jan.

  PMID: 36855475 BACKGROUND

• Reysner T, Kowalski G, Mularski A, Pyszczorska M, Grochowicka M, Perek A, Daroszewski P, Reysner M. Perineural dexamethasone effectively prolongs anaesthesic block duration in total hip arthroplasty, reduces opioid consumption, and does not compromise motor function, nerve integrity, or glycaemic control. Int Orthop. 2025 Aug;49(8):1791-1799. doi: 10.1007/s00264-025-06578-1. Epub 2025 Jun 11.

  PMID: 40498110 BACKGROUND

• Reysner T, Neumann-Podczaska A, Pietraszek P, Mularski A, Kowalski G, Daroszewski P, Reysner M. Reduced Ropivacaine Volume with Perineural Dexamethasone in PENG Block for Total Hip Arthroplasty: A Randomized Controlled Trial. J Clin Med. 2025 Dec 9;14(24):8722. doi: 10.3390/jcm14248722.

  PMID: 41464623 BACKGROUND

• Zufferey PJ, Chaux R, Lachaud PA, Capdevila X, Lanoiselee J, Ollier E. Dose-response relationships of intravenous and perineural dexamethasone as adjuvants to peripheral nerve blocks: a systematic review and model-based network meta-analysis. Br J Anaesth. 2024 May;132(5):1122-1132. doi: 10.1016/j.bja.2023.12.021. Epub 2024 Jan 27.

  PMID: 38281844 BACKGROUND

• Kim JY, Kim J, Kim DH, Han DW, Kim SH, Kim D, Chung S, Yu S, Lee UY, Park HJ. Anatomical and Radiological Assessments of Injectate Spread Stratified by the Volume of the Pericapsular Nerve Group Block. Anesth Analg. 2023 Mar 1;136(3):597-604. doi: 10.1213/ANE.0000000000006364. Epub 2023 Feb 17.

  PMID: 36727847 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

• Yeoh SR, Chou Y, Chan SM, Hou JD, Lin JA. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks. Healthcare (Basel). 2022 Aug 18;10(8):1565. doi: 10.3390/healthcare10081565.

  PMID: 36011222 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

MeSH Terms

Conditions

Pain, Postoperative; Muscle Weakness

Interventions

Dental Occlusion; Bupivacaine; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Mohamed F Morsi, M.B., B.Ch., M.Sc.

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Azza A AbdelAleem, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mohamed F Morsi, M.B., B.Ch., M.Sc.

CONTACT

+201116618163; MohamedMorsi@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the outcome assessors, and the data analyst will be blinded to group allocation. All postoperative pain and motor assessments will be performed by a single anaesthesiologist who is blinded to group allocation and who is not involved in randomization, block performance, or intraoperative care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Intensive Care Unit and Pain Management.

Model Details: Patients will be randomly allocated into two equal parallel groups: Group A (standard-volume PENG block: 20 mL bupivacaine 0.25%) and Group B (low-volume PENG block with dexamethasone: 10 mL bupivacaine 0.25% with 4 mg dexamethasone).

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 14, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results, for a period of 3 years.
• Access Criteria: Requests from qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and the Research Ethics Committee, Faculty of Medicine, Ain Shams University, and a signed data access agreement.

Locations

EG (1)