PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

Study Overview
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Brief Summary
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To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.

Detailed Description
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The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.

Official Title
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Pericapsular Nerve Group (PENG) Block vs Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Hip Arthroplasty: a Randomized Non-inferiority Trial

Conditions
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Total Hip Arthroplasty, Postoperative Pain

Intervention / Treatment
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* Procedure: Pericapsular nerve group (PENG) block
* Procedure: Spinal anesthesia
* Drug: Intrathecal morphine
* Procedure: Sham PENG block
* Drug: Intrathecal placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent Exclusion Criteria: patient unwilling / unable to provide informed consent contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy) high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV) preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition) pregnancy substance abuse Post Randomization Exclusion Criteria: change of surgical plan violation of 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
Interventional Model Description: Non-inferiority randomized triple-blinded controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PENG block<br>Patients scheduled for primary total hip arthroplasty after receiving spinal anesthesia will undergo pericapsular nerve group (PENG) block. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone | Procedure: Pericapsular nerve group (PENG) block<br>* A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and 20ml 0.5% levobupivacaine with 2mg (0.5ml) dexamethasone injected (total volume of injectate 20.5ml) between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule<br>Procedure: Spinal anesthesia<br>* Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally<br>Drug: Intrathecal placebo<br>* 0.5ml of placebo solution (0.9%NaCl) is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)<br>|
| Active Comparator: Intrathecal morphine<br>Patients scheduled for primary total hip arthroplasty will receive spinal anesthesia with local anesthetic and morphine administered intrathecally. After onset of spinal anesthesia a sham PENG block will be performed. Postoperative multimodal analgesia with paracetamol, etoricoxib and oxycodone. | Procedure: Spinal anesthesia<br>* Spinal anesthesia will be performed at the level of the presumed interspace in-between the third and fourth lumbar vertebrae by introducing a 27 gauge pencil-point spinal needle and 15mg of levobupivacaine (3ml) injected intrathecally<br>Drug: Intrathecal morphine<br>* 100 micrograms of preservative free morphine diluted to a volume of 0.5ml is added to the local anesthetic solution injected for spinal anesthesia (total injectate volume 3.5ml)<br>Procedure: Sham PENG block<br>* A 22 gauge 120mm nerve block needle will be introduced under ultrasound guidance in plane from superolateral to posteromedial to position the needle tip posterolateral to the ileopsoas tendon in-between the anterior inferior iliac spine and the ileopubic (ileopectineal) eminence and a placebo solution consisting of 20.5ml 0.9%NaCl injected between the tendon and the inferior pubic ramus just proximal to the attachment of the anterior hip capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain at rest | maximum pain on a numerical rating scale at rest over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes | 48 postoperative hours | 
| Maximum pain with active hip flexion | maximum pain on a numerical rating scale with active 60 degrees hip flexion over first 48 post-operative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes | 48 postoperative hours | 
| cumulative morphine equivalent dose over 48 post-operative hours | cumulative opioid consumption including morphine rescue analgesia will be recorded during the first 48 postoperative hours Test treatment (PENG block) is to be considered non-inferior to reference treatment (intrathecal morphine) only if during final data analysis conditions of non-inferiority are met for all 3 co-primary outcomes | 48 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps muscle motor block | Quadriceps muscle motor function will be evaluated by a straight leg raise test performed at 4,6,12,20 and 24 hours postoperatively | 24 postoperative hours | 
| Opioid side effects | The presence of pruritus, nausea and vomiting, hypotension and need for rescue antiemetic medication (ondansetron) will be monitored and recorded | 48 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Postoperative pain, Anesthesia, Regional