PENG Block Combined to Wound Infiltration for Hip Replacement

Study Overview
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Brief Summary
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This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement. Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.

Official Title
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Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial

Conditions
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Postoperative Pain, Analgesia, Hip Arthropathy, Acute Pain, Pain, Postoperative Complications

Intervention / Treatment
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* Procedure: PENG block
* Procedure: Wound Infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective hip replacement surgery ASA physical status score < 4 Exclusion Criteria: Contraindications to regional anesthesia ASA physical status score ≥ 4 Patient's refusal or inability to sing the informed consent Pre-operatively therapy with opioids Allergies to any drug provided by the study protocol

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENG BLOCK AND WOUND INFILTRATION<br>Participants receiving PENG block combined to wound infiltration | Procedure: PENG block<br>* After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.<br>Procedure: Wound Infiltration<br>* At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.<br>|
| Active Comparator: WOUND INFILTRATION<br>Participants receiving wound infiltration alone | Procedure: Wound Infiltration<br>* At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Pain Score | 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 during 48 h after surgery | 24 hours | 
| Total opioids consumption | Total of Sublingual Sufentanil tablets released | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first opioid | Time (hours) from the end of surgery to the first opioid administration | 48 hours | 
| Range of hip motion | Degrees of hip flexion | 24 hours | 
| Time to ambulation | Time until the patient is able to stand up and walk with or without assistive devices | 48 hours | 
| Quadriceps weakness | Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion | 48 hours | 
| Incidence of block complications | Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. | 48 hours | 
| Opioids side effects | The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia, hip surgery, PENG