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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406010
• Other study ID #: PENG for PAO
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: Matias Vested
• Phone: +4535455747
• Email: matias.vested[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 5mg/ml 20ml
administered in a pericapsular nerve group (PENG) block
• Saline 0.9%
administered in a pericapsular nerve group (PENG) block

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Matias Vested

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	within 3 hours
Secondary	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	within 5 hours
Secondary	Opioid use 24 hours	Opioid use from tracheal extubation until 24 hours postoperatively	24 hours
Secondary	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	within 24 hours
Secondary	First opioid	Time to first opioid	within 24 hours
Secondary	Last opioid	Time to last opioid	within a week
Secondary	Time to first PONV-medication	Time to first PONV-medication	within 24 hours
Secondary	Opioid use at PACU	Opioid use at PACU	within 24 hours
Secondary	Sleep quality/pain during sleep.	During the first postoperative night the patients answer yes/no to whether they awoke from their sleep because of pain.	within 24 hours
Secondary	Length of stay at hospital	Length of stay at hospital	within a week
Secondary	Length of time to fulfilling PACU discharge criteria	Length of time to fulfilling PACU discharge criteria	within 24 hours
Secondary	Defecation	Time to first defecation	within 24 hours