PENG Block for Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.

Detailed Description
-----------------
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

Official Title
-----------------
Periarticular Nerve Group (PENG) Block for Postoperative Rehabilitation in Total Hip Arthroplasty: a Randomized Controlled Trial

Conditions
-----------------
Hip Osteoarthritis, Hip Arthropathy, Hip Disease, Hip Pain Chronic

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5% Injectable Solution
* Drug: 0,9% normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old undergoing unilateral total hip arthroplasty Exclusion Criteria: refusal to participate < 18 yo Chronic opioid use localized infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG with 20mL 0,5% Ropivacaine<br>Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. | Drug: Ropivacaine 0.5% Injectable Solution<br>* 20 mL 0.5% ropivacaine will be injected for the PENG block<br>* Other names: Ropimol;|
| Experimental: PENG block with 20mL 0,9% normal saline<br>Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. | Drug: 0,9% normal saline<br>* 20 mL 0.9% normal saline will be injected for the PENG block<br>* Other names: placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 2 | 
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 3 | 
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid consumption | milligrams of intravenous morphine equivalents | 96 hours postoperatively | 
| Time to first opioid | Hours to first administration of an intravenous opioid drug | 96 hours postoperatively | 
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 1 | 
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 2 | 
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 3 | 
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Day 4 | 
| Functional assessment: getting out of bed without help | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery | 
| Functional assessment: active elevation of the operated limb | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery | 
| Functional assessment: independent verticalization- by the balcony | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery | 
| Functional assessment: walking by the balcony | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain management, periarticular nerve group block, total hip arthroplasty, multimodal analgesia, regional anesthesia