NCT06964282

Brief Summary

Background: In recent years, regional anesthesia has become more popular because it can reduce pain and the need for strong pain medications like morphine. For hip surgery, the PENG block is already known to be effective. A newer method, called the iliopsoas plane block (IPB), is very similar and has also shown good results in hip arthroscopy. However, these two techniques have never been directly compared in patients undergoing hip replacement surgery using the posterior approach. Goal: This study aims to see if the IPB is just as effective as the PENG block for controlling pain and helping patients recover well after hip replacement surgery. Method: 118 adult patients scheduled for hip replacement under spinal anesthesia will be randomly assigned to receive either: IPB: 7 ml of Ropivacaine 7.5 mg/ml PENG: 14 ml of Ropivacaine 3.75 mg/ml Both injections are given under ultrasound guidance 30 minutes before spinal anesthesia. Neither the patient, the surgeon, nor the data collector will know which technique was used. Post-Surgery Care: All patients will receive standard pain relief, including: Paracetamol every 6 hours Etoricoxib once a day Morphine via a patient-controlled pump for 48 hours Main Outcome Measured: The primary goal is to compare pain during movement 6 hours after surgery, using a pain scale from 0 (no pain) to 10 (worst pain). The study will consider the two blocks equivalent if the difference in average pain scores is less than 1 point. Other Outcomes: Total morphine used in 48 hours Pain scores at rest and during movement at various time points Walking ability (2- and 6-minute walk tests, and timed-up-and-go test) Quality of recovery (using the QoR-15 questionnaire) Side effects of morphine Patient satisfaction Length of hospital stay Safety: Both techniques are safe and already used in clinical practice. Ultrasound guidance minimizes risks like nerve injury, bleeding, or infection. Conclusion: If the IPB is shown to be as effective as the PENG block, both can be considered reliable options for pain control and early recovery after hip replacement surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

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 Progress59%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

April 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 30, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic Pain 6h postoperative

    Dynamic pain score (during mobilization) at 6 hours postoperatively, measured on a 0-10 numeric rating scale (NRS). Equivalence is defined as a mean difference of less than 1 point on the NRS.

    6 hours after surgery

Secondary Outcomes (10)

  • Total Morphine Consumption

    First postoperative 48 hours

  • NRS Dynamic pain

    First postoperative 48 hours

  • NRS Rest pain

    First postoperative 48 hours

  • 2MWT

    First postoperative 48 hours

  • 6MWT

    First postoperative 48 hours

  • +5 more secondary outcomes

Study Arms (2)

Group PENG

ACTIVE COMPARATOR

Patients will receive a pericapsular nerve group block with 14 ml of ropivacaine 3.75 mg/ml, administered 30 minutes prior to spinal anesthesia.

Procedure: PENG Block

IPB Group

ACTIVE COMPARATOR

Patients will receive an iliopsoas plane block with 7 ml of ropivacaine 7.5 mg/ml, administered 30 minutes prior to spinal anesthesia.

Procedure: Iliopsoas nerve block

Interventions

PENG BlockPROCEDURE

Also performed under ultrasound guidance with an 80 mm B-Braun X360 needle and a 3-5 MHz curved probe. The femoral nerve, femoral artery, iliopsoas muscle, and pubic ramus are identified. The needle is inserted in-plane, and 14 ml of ropivacaine 3.75 mg/ml is injected between the psoas tendon and pubic ramus.

Group PENG

Performed under ultrasound guidance with a curvilinear probe (5-2 MHz). The transducer is positioned transversely below the anterior superior iliac spine (ASIS), then pivoted medially. After identifying the femoral head and acetabular rim, a 22G 80 mm needle is inserted in-plane to reach the iliopsoas plane, lateral to the iliopsoas tendon. 7 ml of ropivacaine 7.5 mg/ml is then injected.

IPB Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age \>18 years) ASA physical status classification I-III Scheduled for elective posterior approach total hip arthroplasty (THA) under spinal anesthesia

You may not qualify if:

  • Pregnancy (confirmed by beta-HCG test if applicable) Known peripheral neuropathy or major neurological disease Chronic pain syndromes or long-term opioid use (\>20 mg oral morphine equivalents/day) Severe hepatic or renal insufficiency Allergy to local anesthetics Major coagulopathies Vulnerable patients (e.g., minors, legally protected individuals)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liege University Hospital

Liège, 4000, Belgium

RECRUITING

Study Officials

  • Michele Carella, MD, PhD, ESRA-DRA

    Liège University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Carella, MD, PhD, ESRA-DRA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient, the surgeon, and the postoperative data collector will be blinded to the allocation. Only the anesthesiologist performing the block (who is not involved in patient follow-up or data collection) will know the specific technique and dosage used
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, double-blind, controlled equivalence trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 9, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 10, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Patient data will be anonymized and collected via the REDCap platform, compliant with current data protection regulations. Only the principal investigator and authorized study personnel will have access. Data will be stored securely for 10 years.

Locations