NCT07109388

Brief Summary

The aim of this clinical trial is to compare the analgesic effect of a pericapsular nerve group (PENG) block with a combined femoral, sciatic, lateral femoral cutaneous nerve block for postoperative analgesia in patients scheduled for secondary total hip arthroplasty. The primary objective of this study is to compare postoperative pain management between the PENG block and the combined block (femoral, sciatic, lateral femoral cutaneous) by measuring postoperative morphine consumption in each of the two groups. Participants will be randomized into two groups. Patients assigned to the PENG group will receive a PENG block with ropivacaine, followed by a sham (sciatic) block, and spinal anesthesia with isobaric bupivacaine. Patients assigned to the combined block group will receive femoral, sciatic, lateral femoral cutaneous nerve blocks with ropivacaine, followed by spinal anesthesia with isobaric bupivacaine.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet 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 Progress31%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

July 7, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

July 7, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

nerve blockpostoperative painhip arthroplasty replacement

Outcome Measures

Primary Outcomes (1)

  • Cumulative postoperative morphine consumption at day 1

    Description: total consumption in mg

    Time Frame: 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

  • +4 more secondary outcomes

Study Arms (2)

PENG group

EXPERIMENTAL

Pericapsular nerve group block

Drug: Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound

Combined nerve block

ACTIVE COMPARATOR

Combined femoral, sciatic, lateral femoral cutaneous nerve block

Drug: Femoral, sciatic and lateral femoral cutaneous nerve block with 0.375% ropivacaine

Interventions

Participants in the PENG group will first receive a sham sciatic injection; the needle will be inserted into the subcutaneous tissue and 3 ml of 0.9% NaCl will be injected. They will then receive a PENG nerve block in the supine position. A low-frequency (2-5 MHz) curvilinear ultrasound probe (BK Ultrasound) will be used to identify the anterior inferior iliac spine, the pubic eminence, and the psoas tendon with its fascial plane. A 22-gauge, 50 mm needle (SonoPlex® Pajunk) will be inserted into the fascial plane to inject 20 ml of 0.75% ropivacaine (Fresenius Kabi).

Also known as: PENG block
PENG group

Participants in the combined group will first receive a sciatic nerve block performed with the patient in a semi-prone position, the lower limb flexed at 90° (hip and knee), elevated with a cushion placed between the legs. A straight line will be drawn between the greater trochanter and the ischial tuberosity. The sciatic nerve is located approximately at the midpoint of this line. Under ultrasound guidance, the ischial tuberosity will be identified medially, the greater trochanter laterally, the gluteus maximus muscle superficially beneath the adipose tissue, and the quadratus femoris muscle in depth. A 22-gauge, 50 mm needle will then be inserted into the fascial plane to inject 20 ml of 0.375% ropivacaine. The patient is then placed supine for femoral and lateral femoral cutaneous nerve blocks. 15 ml of local anaesthetics will be injected around the femoral nerve and 5 around the lateral femoral cutaneous nerve.

Combined nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 secundary 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
  • Morbid Obésity III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • She C, Liu H. The efficacy of pericapsular nerve group block for reducing pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024 Apr 8;19(1):229. doi: 10.1186/s13018-024-04707-x.

    PMID: 38584259BACKGROUND
  • Newman JT, Briggs KK, McNamara SC, Philippon MJ. Outcomes After Revision Hip Arthroscopic Surgery in Adolescent Patients Compared With a Matched Cohort Undergoing Primary Arthroscopic Surgery. Am J Sports Med. 2016 Dec;44(12):3063-3069. doi: 10.1177/0363546516659656. Epub 2016 Aug 11.

    PMID: 27514736BACKGROUND
  • Bohl DD, Samuel AM, Basques BA, Della Valle CJ, Levine BR, Grauer JN. How Much Do Adverse Event Rates Differ Between Primary and Revision Total Joint Arthroplasty? J Arthroplasty. 2016 Mar;31(3):596-602. doi: 10.1016/j.arth.2015.09.033. Epub 2015 Sep 28.

    PMID: 26507527BACKGROUND
  • Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005.

    PMID: 12533568BACKGROUND
  • 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.

    PMID: 17403800BACKGROUND
  • Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19.

    PMID: 32151524BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental OcclusionRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Eric Albrecht, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Med. Eric Albrecht, Associate Professor, University of Lausanne

Study Record Dates

First Submitted

July 7, 2025

First Posted

August 7, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share