Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406010
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-30
Brief Title:
Investigating the Effect of Pericapsular Nerve Group PENG Block on Postoperative Pain After Peri-acetabular Osteotomy
Sponsor:
Matias Vested
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Blinded Randomized Study Investigating the Effect of Pericapsular Nerve Group PENG Block on Postoperative Pain After Peri-acetabular Osteotomy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mgmL 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 mgml vs placebo The investigators hypothesize that patients given ropivacaine 5 mgml will have less pain in the first 24 postoperative hours compared with patients given placebo
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 mgml vs placebo The investigators hypothesize that patients given ropivacaine 5 mgml will have less pain in the first 24 postoperative hours compared with patients given placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None