IPACK or Selective Tibial Nerve Block for ACL Reconstruction With an Adductor Canal Block

Study Overview
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Brief Summary
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The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.

Detailed Description
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The hypothesis of this study is that a combined adductor canal and selective tibial nerve block provides better analgesia than a combined adductor canal block and IPACK in patients undergoing anterior cruciate ligament reconstruction. This randomized controlled trial will include two groups: an adductor canal block plus IPACK group (group IPACK) and an adductor canal block plus tibial selective nerve block group (group TIBIAL). After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization. Prior to surgery, all patients will have an adductor canal block with 20ml of ropivacaine 0.75%. In group TIBIAL the patient will receive in addition a selective tibial nerve block with 5 ml of ropivacaine 0.75%. In group IPACK the patient will receive in addition an IPACK with 20ml of ropivacaine 0.2%. In both groups, patients will have the surgery under general anaesthesia with a multimodal analgesic regimen inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg. 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 include cumulative morphine consumption at 2h and 48h postoperatively, rest and dynamic pain scores and rate of PONV at 2 h, 24 h and 48 h postoperatively. Early functional-related outcomes include range of motion, strength and walking distance at 24 h and 48 h postoperatively. Late functional-related outcomes include range of motion, strength, hop distance, agility test, Y balance test, Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) and International Knee Documentation Committee Scale (IKDC) at 4 and 8 months postoperatively.

Official Title
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Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Scheduled for Anterior Cruciate Ligament Reconstruction Under General Anaesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial

Conditions
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Analgesia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA score I-III 18 years or older Scheduled for elective primary ACL reconstruction Signature of consent form Exclusion Criteria: Refusal or inability for informed consent Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason 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) Pregnancy or lactating 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIBIAL group<br>All patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery, | 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 anaesthetics around the nerve.<br>|
| Active Comparator: IPACK group<br>All patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery. | Procedure: IPACK<br>* The IPACK 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 twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intravenous morphine consumption | Consumption in mg | 1 day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intravenous morphine consumption | Consumption in mg | 2 hours and 2 days postoperatively | 
| Resting and dynamic pain score | Numeric Rating Scale (NRS), 0-10 where 0 is no pain and 10 is the worst pain imaginable | 2 hours, 1 day and 2 days postoperatively | 
| Incidence of postoperative nausea and vomiting | Presence of nausea and vomiting in the postoperative period | 2 hours, 1 day and 2 days postoperatively | 
| Range of motion | Joint motion in degrees | 1 day and 2 days postoperatively | 
| Quadriceps strength | Ordinal scale of 1-5, with 5 being the maximal developed strength compared with the opposite side | 1 day and 2 days postoperatively | 
| Walking distance | Distance in meters | 1 day and 2 days postoperatively | 
| Range of motion | Joint motion in degrees | 4 months and 8 months postoperatively | 
| Concentric quadriceps strength and concentric hamstring strength | Percentage of strength as compared with the opposite leg | 4 months and 8 months postoperatively | 
| Single hop distance, triple hop distance and crossover triple hop distance | Percentage of distance as compared with the opposite leg | 4 months and 8 months postoperatively | 
| Agility test | Time in second | 4 months and 8 months postoperatively | 
| Y balance test | Distance in cm | 4 months and 8 months postoperatively | 
| Anterior Cruciate Ligament Return to Sport After Injury Scale score | Score in percentage | 4 months and 8 months postoperatively | 
| International Knee Documentation Committee Scale score | Score in percentage | 4 months and 8 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, Selective tibial nerve block, IPACK, Anterior cruciate ligament reconstruction, Multimodal analgesia, Local anesthetics