Clinical trial NCT06179641: Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Arthropathy of Knee
Postoperative Pain
Keywords: nerve block
pain management
postoperative pain
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single centered, prospective, randomized double blinded controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total iv morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Morphine consumption in the recovery room
timeFrame: From admission till discharge from the recovery room, up to 2 hours
measure: PCA administered morphine consumption
timeFrame: at day 1, day 2 and day 3 postoperatively
measure: rest and dynamic pain scores
timeFrame: at day 1, day 2 and day 3 postoperatively
measure: Duration of peripheral nerve block
timeFrame: From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours
measure: Incidence of postoperative nausea and vomiting
timeFrame: at day 1, day 2 and day 3 postoperatively
measure: Incidence of pruritus
timeFrame: at day 1, day 2 and day 3 postoperatively
measure: peroneal nerve block
timeFrame: at day 1, day 2 and day 3 postoperatively
measure: complications of peripheral nerve blocks
timeFrame: at the moment of execution of the block (day 0) and at day 3 postoperatively
measure: passive and active motion range
timeFrame: at day 3 postoperatively
measure: quadriceps strength
timeFrame: at day 3 postoperatively
measure: walking distance
timeFrame: at 72h postoperatively
measure: hospital stay
timeFrame: from admission to the hospital till discharge, up to 3 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
state: Vaud
Study officials:
References:
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citation: Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
citation: Paulou F, Wegrzyn J, Rossel JB, Gonvers E, Antoniadis A, Kagi M, Wolmarans MR, Lambert J, Albrecht E. Analgesic efficacy of selective tibial nerve block versus partial local infiltration analgesia for posterior pain after total knee arthroplasty: a randomized, controlled, triple-blinded trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101223. doi: 10.1016/j.accpm.2023.101223. Epub 2023 Apr 6.