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

ConditionAnesthesia, Local
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatias Vested

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine 5mg/ml 20ml

    Drug

    administered in a pericapsular nerve group (PENG) block

  • Saline 0.9%

    Drug

    administered in a pericapsular nerve group (PENG) block

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Ropivacaine groupExperimental treatment 1 intervention
Group B: Saline groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
24 hours postoperatively

Secondary outcomes

1

Presence of moderate to severe pain

The number of patients reporting moderate to severe pain at rest \[\>3 out of 10 on a numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable)\] 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.

Time frame
within 3 hours
2

Pain during mobilization

Pain during during mobilization (from laying down in bed till standing on the floor) assessed on numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) at 5 hours after extubation

Time frame
within 5 hours
3

Opioid use 24 hours

Opioid use from tracheal extubation until 24 hours postoperatively

Time frame
24 hours
4

Pain during mobilization

Pain during during mobilization (from laying down in bed till standing on the floor) assessed on numeric rating scale (NRS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable) at: * postoperative day one between 8 and 10 pm * 24 hours after extubation

Time frame
within 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matias Vested

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
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