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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06406010
Enrollment
90
Registered
2024-05-09
Start date
2024-08-19
Completion date
2027-03-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

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).

Detailed description

Peri-acetabular osteotomy (PAO) is the joint-preserving treatment of choice in young adults with symptomatic hip dysplasia. However, moderate to severe pain occurs frequently in the postoperative period. Pain after PAO comes primarily from the anterior hip capsule which is innervated by the terminal nerves of the lumbar plexus comprising branches from the femoral, obturator and accessory obturator nerves. The articular branches from the femoral nerve reach the plane between the iliopsoas muscle and the iliofemoral ligament (iliopsoas plane) and innervate the anterior and lateral aspects of the hip capsule. The articular branches innervate the anterior and medial aspects of the hip capsule and the accessory obturator nerve contributes to the innervation of the hip in 10%-30% of the patients, and supplies the inferomedial aspect of the hip capsule. The PAO procedure, involving three osteotomies in otherwise healthy individuals, is likely to produce a substantial surgical stress response, which potentially could be alleviated by multimodal analgesia including the pericapsular nerve group (PENG) block. The PENG block is a novel regional anaesthesia technique that has been proposed as an effective motor-sparing block for total hip arthroplasty. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves. Its potential analgesic and motor-sparing effect is desirable for early ambulation, better physical therapy, and earlier discharge. Conventional opioid-sparing regional anaesthetic techniques such as lumbar plexus and femoral nerve blocks are effective but carry a risk of undesirable lower limb muscle weakness. Alternatively, the fascia iliaca block does not consistently provide adequate pain relief for hip surgeries. The anterior capsule of the hip has a high density of nociceptors and mechanoreceptors and appears to be the primary source of pain after hip surgery. The PENG block targets the articular branches providing innervation to the anterior capsule of the hip joint, including the femoral, obturator and accessory obturator nerves. A recent study reported improved quality of recovery and reduced opioid requirements for patients undergoing primary THA whereas other studies have reported conflicting results regarding the analgesic efficacy for THA. However, the effect of PENG on PAO has not been investigated. Thus, in order to investigate if PENG block is superior to placebo in decreasing immediate pain and other complications after PAO, the investigators aim to conduct a randomised, double-blinded trial of ropivacaine 5 mg/ml vs. placebo. The investigators hypothesize that patients given ropivacaine 5 mg/ml will have less pain in the first 24 postoperative hours compared with patients given placebo.

Interventions

DRUGRopivacaine 5mg/ml 20ml

administered in a pericapsular nerve group (PENG) block

DRUGSaline 0.9%

administered in a pericapsular nerve group (PENG) block

Sponsors

Matias Vested
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Pain during first 24 hours postoperatively24 hours postoperativelyArea 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

Secondary

MeasureTime frameDescription
Presence of moderate to severe painwithin 3 hoursThe 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.
Pain during mobilizationwithin 5 hoursPain 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
Opioid use 24 hours24 hoursOpioid use from tracheal extubation until 24 hours postoperatively
First opioidwithin 24 hoursTime to first opioid
Last opioidwithin a weekTime to last opioid
Time to first PONV-medicationwithin 24 hoursTime to first PONV-medication
Opioid use at PACUwithin 24 hoursOpioid use at PACU
Sleep quality/pain during sleep.within 24 hoursDuring the first postoperative night the patients answer yes/no to whether they awoke from their sleep because of pain.
Length of stay at hospitalwithin a weekLength of stay at hospital
Length of time to fulfilling PACU discharge criteriawithin 24 hoursLength of time to fulfilling PACU discharge criteria
Defecationwithin 24 hoursTime to first defecation

Countries

Denmark

Contacts

CONTACTMatias Vested
matias.vested@regionh.dk+4535455747
STUDY_CHAIRMatias Vested, Md, PhD

Rigshospitalet University of Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026