Pericapsular Nerve Group Block for Elective Hip Arthroplasty

Study Overview
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Brief Summary
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This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.

Detailed Description
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Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty. Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients. The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.

Official Title
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Pericapsular Nerve Group Block for Analgesia After Hip Arthroplasty: a Randomized Double-Blind, Placebo-Controlled Trial.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: PENG Block with local anesthetic
* Procedure: PENG Block with 0,9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective total hip arthroplasty General anesthesia Enhanced Recovery Program Exclusion Criteria: American Society of Anesthesiologists (ASA) Score > 2 Drug allergy Significant psychiatric disturbances Preoperative opioid use Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid Body Mass Index > 40 kg/m²

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG group<br>PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine | Procedure: PENG Block with local anesthetic<br>* After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.<br>|
| Placebo Comparator: Placebo group<br>PENG block with 20 ml of 0,9% saline | Procedure: PENG Block with 0,9% saline<br>* After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on first Mobilization | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery | Postoperative time until midnight day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Pain Score in Post-Anaesthesia Care Unit | Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) | Through postoperative time during Post Anesthesia Care Unit stay at day 0 | 
| Morphine Consumption at Day 0 | Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0 | Postoperative time until midnight day 0 | 
| Piritramid Consumption | Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward | Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0 | 
| Morphine Consumption at Day 1 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1 | Postoperative time during Post Anesthesia Care Unit stay at day 0 | 
| Morphine Consumption at Day 2 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2 | Postoperative time until midnight day 2 | 
| Pain Score at Rest 2h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery | 2 hours after surgery | 
| Pain Score on mobilization 2h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery | 2 hours after surgery | 
| Pain Score at Rest 4h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery | 4 hours after surgery | 
| Pain Score on mobilization 4h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery | 4 hours after surgery | 
| Pain Score at Rest 6h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery | 6 hours after surgery | 
| Pain Score on mobilization 6h Postop | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery | 6 hours after surgery | 
| Pain Score at Rest Day 1 AM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1 | Day 1 in the morning after surgery | 
| Pain Score on mobilization Day 1 AM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1 | Day 1 in the morning after surgery | 
| Pain Score at Rest Day 1 PM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1 | Day 1 in the afternoon after surgery | 
| Pain Score on mobilization Day 1 PM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1 | Day 1 in the afternoon after surgery | 
| Pain Score at Rest Day 2 AM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2 | Day 2 in the morning after surgery | 
| Pain Score on mobilization Day 2 AM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2 | Day 2 in the morning after surgery | 
| Pain Score at Rest Day 2 PM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2 | Day 2 in the afternoon after surgery | 
| Pain Score on mobilization Day 2 PM | A visual analog pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2 | Day 2 in the afternoon after surgery | 
| First Mobilization Success | Success rate of patients mobilized the day of surgery | Postoperative time until midnight day 0 | 
| Mean remifentanil Infusion Rate | Total infused remifentanil dose per kg body weight per minute of total operative time | Intraoperatively | 
| Quadriceps weakness | Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance. | Through postoperative time during Post Anesthesia Care Unit stay at day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective Hip Surgery, PENG Block