Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy

NCT06406010 | Recruiting Phase 4 DMC

• 1 other identifier: PENG for PAO
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mg/mL or saline (placebo) in patients undergoing PAO. The hypothesis of this study is that PENG block with ropivacaine reduces postoperative pain compared to placebo (saline).

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Pain during first 24 hours postoperatively

  Area under curve (AUC) of pain reported on a numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) during the first 24 hours postoperatively

  24 hours postoperatively

Secondary Outcomes (12)

• Presence of moderate to severe pain

  within 3 hours

• Pain during mobilization

  within 5 hours

• Opioid use 24 hours

  24 hours

• Pain during mobilization

  within 24 hours

• First opioid

  within 24 hours

Study Arms (2)

Ropivacaine group

EXPERIMENTAL

Ropivacaine 5 mg/ml 20ml

Drug: Ropivacaine 5mg/ml 20ml

Saline group

PLACEBO COMPARATOR

NaCl 0.9%

Drug: Saline 0.9%

Interventions

Ropivacaine 5mg/ml 20ml DRUG

administered in a pericapsular nerve group (PENG) block

Ropivacaine group

Saline 0.9% DRUG

administered in a pericapsular nerve group (PENG) block

Saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old
• Informed consent
• Scheduled for periacetabular osteotomy under general anesthesia with intubation
• American Society of Anesthesiologists (ASA) physical status classification I to III
• Can read and understand Danish

You may not qualify if:

• Known allergy to ropivacaine
• Daily use of opioids, gabapentin or tricyclic antidepressant (regardless of dose) within the last four weeks prior to surgery
• Contraindications to Celocoxib, NSAIDs or paracetamol

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matias Vested, Md, PhD

  Rigshospitalet University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Matias Vested

CONTACT

+4535455747; matias.vested@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: Randomized study

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 9, 2024
• Study Start: August 19, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)