PENG Block vs Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After THA: a Randomized Controlled Non-inferiority Clinical Trial.

Study Overview
=================
Brief Summary
-----------------
To compare the impact of pericapsular nerve group block (PENG) versus the supra-inguinal fascia-iliaca compartment block (SFICB) in postoperative analgesia, opioid sparing and enhanced recovery after surgery of total hip arthroplasty by poster-lateral approach.

Detailed Description
-----------------
ASA physical status 1, 2 and 3 patients scheduled to undergo elective total hip arthroplasty by poster-lateral (Moore) surgical approach with spinal anesthesia. The investigators want to confirm the non-inferiority of the SFICB compared to the PENG block on postoperative first 6 hours after surgery NRS pain score and 48 hours opioids consumption, and the difference between these in terms of early recovery and motor impact on two first day after surgery. The principal investigator perform these regional anesthesia techniques with ultrasound guided injections.

Official Title
-----------------
Comparison of Ultrasound-guided PENG Block and Supra-inguinal Fascia Iliaca Compartment Block for Postoperative Opioids Consumption and Early Motor Recovery After Total Hip Arthroplasty: a Randomized Controlled Non-inferiority Clinical Trial.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Pericapsular nerves group (PENG) block
* Procedure: Supra-inguinal fascia-iliaca compartment block
* Drug: Ropivacaine 0,75% in PENG block
* Drug: Ropivacaine 0,375% in SFICB block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults patients scheduled to undergo elective primary total hip arthroplasty by posterior surgical approach with spinal anesthesia Exclusion Criteria: Patient refusal Allergy to administrated drugs or local infection Pregnancy History of chronic pain Drugs addiction Mental ou neurological diseases Kidney or liver serious diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PENG block<br>Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block. Patients in PENG group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. | Procedure: Pericapsular nerves group (PENG) block<br>* Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block with injection 20 ml of ropivacaine 0,75%, between the anterior hip articular capsule, the ilii-psoas muscle, the ileo-pubic eminence and the antero-inferior iliac spine.<br>Drug: Ropivacaine 0,75% in PENG block<br>* 20 ml injection of ropivacaine 0,75%<br>|
| Active Comparator: SFICB block<br>Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block. Patients in SFICB group receive multimodal postoperative analgesia techniques coupled with morphine PCA pump. | Procedure: Supra-inguinal fascia-iliaca compartment block<br>* Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block with injection over de inguinal ligament of 40 ml of ropivacaine 0,375%, between de ilio-psoas muscle and internal oblique muscle.<br>Drug: Ropivacaine 0,375% in SFICB block<br>* 40 ml injection of ropivacaine 0,375%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS 6 hours | The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores on 0 to 10 scale. | 6 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walk test | Difference in traveled distance (metres) at six minutes walking test 48 hours after surgery | 48 jours after surgery | 
| Opioids secondaires side effects | Incidence of morphine related side effects in two groups | 48 hours after surgery | 
| QoR-15 | QoR-15 French validated questionnaire for the evaluation of recovery after surgery | 72 hours after surgery | 
| 2 minutes walk test | Difference in traveled distance (metres) at two minutes walking test 24 hours after surgery | 24 hours after surgery | 
| Opioid sparing | Difference in cumulated morphine consumption in first 48 hours after surgery | 48 hours after intervention | 
| DN4 | Difference between the two groups in the DN4 questionnaire to assess the risk of persistent pain after surgery. | 72 hours after surgery | 
| IPO | Pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS- POQ-R). | 72 hours after surgery |