Pericapsular nerve group (PENG) block for postoperative pain after peri-acetabular osteotomy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

19 Aug 2024 → ongoing

Decision date (initial)

2024-06-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate if pericapsular nerve group (PENG) block is superior to placebo in decreasing immediate pain and other complications after periacetabular osteotomy (PAO)

Secondary objectives 3

1. Occurrence of moderate to severe pain [>3 out of 10 on a numeric rating scale (NRS) from 0 to 10] at any point in the immediate postoperative phase (from arrival at the postoperative anesthetic care unit)
2. Pain during mobilization (from laying down in bed till standing on the floor and walking 5 meters) assessed on a NRS five hours after extubation.
3. Opioid use from tracheal extubation until 24 hours postoperatively

Conditions and MedDRA coding

periacetabular osteotomy

Regulatory references

Plan to share IPD

Yes

IPD plan description

Data may be shared upon reasonable request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 3

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Area under curve (AUC) of pain reported on a numeric rating scale (NRS) from 0 to 10 during the first 24 hours postoperatively

Secondary endpoints 3

1. The number of patients reporting moderate to severe pain at rest [>3 out of 10 on a numeric rating scale (NRS) from 0 to 10] at any point in the immediate postoperative phase (from arrival at the PACU until transfer to the ward). NRS will be assessed upon arrival at the PACU and each 30 minutes.
2. Pain during during mobilization (from laying down in bed till standing on the floor) assessed on a NRS at 5 hours after extubation
3. Opioid use from tracheal extubation until 24 hours postoperatively

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Inge Lehmanns Vej 7

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Matias Vested

Public contact point

Organisation

Rigshospitalet

Contact name

Matias Vested

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications