Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty

Study Overview
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Brief Summary
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The objective of this clinical trial is to compare two regional analgesia techniques in patients undergoing total knee arthroplasty: IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) vs selective tibial nerve block. The main question is whether one of these peripheral blocks is more effective in reducing postoperative pain than the other. All patients will have a spinal block with an adductor canal block. One group will receive an IPACK block and the other group, a selective tibial nerve block. Postoperative pain scores and morphine consumption, among others, will be compared between groups.

Detailed Description
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The aim of this randomized controlled double blinded trail is to compare an analgesic effect of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block vs selective tibial nerve block in patients scheduled for total knee arthroplasty under spinal anesthesia with an adductor canal block. The investigators presume that association of a selective tibial nerve block with an adductor canal block provides better postoperative analgesia than a combination of an IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block with an adductor canal block. The research team plan on including 100 patients and randomly assign them to two groups of 50 patients each. After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization. All patients will receive central spinal anesthesia with 12.5 mg of hyperbaric bupivacaine with 100 mcg of morphine and an adductor canal block with 150 mg of ropivacaine. IPACK block group will then receive an IPACK block with 38 mg of ropivacaine and a tibial nerve group will receive a selective tibial nerve block with 37.5 mg of ropivacaine. During the surgery, iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg. will be administered to all patients. After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting. The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain related outcomes are cumulative morphine consumption in the recovery room, at day 1, day 2 and day 3 postoperatively, rest and dynamic pain scores, duration of peripheral nerve block defined as the time between the execution of the block and the first dose of iv morphine, incidence of postoperative nausea and vomiting and pruritus during 3 days following surgical intervention, incidence of peroneal nerve block and complications of peripheral nerve blocks.

Official Title
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Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial

Conditions
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Analgesia, Arthropathy of Knee, Postoperative Pain

Intervention / Treatment
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* Procedure: Selective tibial nerve block
* Procedure: IPACK block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists classification I-III 18 yo or older patients scheduled for total knee arthroplasty under central spinal anesthesia informed consent signed Exclusion Criteria: Refusal or inability for informed consent Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone Secondary surgical revision Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine Bleeding diathesis Neurological deficit Known renal insufficiency (eGFR <45 ml/min) Known hepatic insufficiency (Child score B or C) Alcohol abuse

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: single centered, prospective, randomized double blinded controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPACK group<br>IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block | Procedure: IPACK block<br>* The IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where nineteen mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anesthetics will be observed above the posterior capsule.<br>|
| Experimental: Tibial nerve group<br>selective tibial nerve block | Procedure: Selective tibial nerve block<br>* The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anesthetics around the nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total iv morphine consumption | consumption in mg | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption in the recovery room | consumption in mg | From admission till discharge from the recovery room, up to 2 hours | 
| PCA administered morphine consumption | consumption in mg administered by PCA | at day 1, day 2 and day 3 postoperatively | 
| rest and dynamic pain scores | Visual Analogue scale(VAS), 0-10 where 0 is no pain and 10 is the worst pain imaginable | at day 1, day 2 and day 3 postoperatively | 
| Duration of peripheral nerve block | Time between execution of a peripheral nerve block and the first dose of iv morphine | From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours | 
| Incidence of postoperative nausea and vomiting | Presence of nausea and vomiting in the postoperative period | at day 1, day 2 and day 3 postoperatively | 
| Incidence of pruritus | Presence of pruritus | at day 1, day 2 and day 3 postoperatively | 
| peroneal nerve block | presence of peroneal nerve block | at day 1, day 2 and day 3 postoperatively | 
| complications of peripheral nerve blocks | iv injection, hematoma, infection | at the moment of execution of the block (day 0) and at day 3 postoperatively | 
| passive and active motion range | joint motion in degrees | at day 3 postoperatively | 
| quadriceps strength | Percentage of strength as compared with the opposite leg | at day 3 postoperatively | 
| walking distance | walking distance without pain | at 72h postoperatively | 
| hospital stay | length of hospital stay in days | from admission to the hospital till discharge, up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve block, pain management, postoperative pain