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

M

Matias Vested

Status and phase

Enrolling
Phase 4

Conditions

Anesthesia, Local

Treatments

Drug: Ropivacaine 5mg/ml 20ml
Drug: Saline 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT06406010
PENG for PAO

Details and patient eligibility

About

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).

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups, including a placebo group

Ropivacaine group
Experimental group
Description:
Ropivacaine 5 mg/ml 20ml
Treatment:
Drug: Ropivacaine 5mg/ml 20ml
Saline group
Placebo Comparator group
Description:
NaCl 0.9%
Treatment:
Drug: Saline 0.9%

Trial contacts and locations

1

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Central trial contact

Matias Vested

Data sourced from clinicaltrials.gov

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