Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty
- Conditions
- AnalgesiaArthropathy of KneePostoperative Pain
- Interventions
- Procedure: IPACK blockProcedure: Selective tibial nerve block
- Registration Number
- NCT06179641
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- American Society of Anesthesiologists classification I-III
- 18 yo or older
- patients scheduled for total knee arthroplasty under central spinal anesthesia
- informed consent signed
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IPACK group IPACK block IPACK (Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee) block Tibial nerve group Selective tibial nerve block selective tibial nerve block
- Primary Outcome Measures
Name Time Method Total iv morphine consumption 24 hours postoperatively consumption in mg
- Secondary Outcome Measures
Name Time Method Incidence of postoperative nausea and vomiting at day 1, day 2 and day 3 postoperatively Presence of nausea and vomiting in the postoperative period
peroneal nerve block at day 1, day 2 and day 3 postoperatively presence of peroneal nerve block
PCA administered morphine consumption at day 1, day 2 and day 3 postoperatively consumption in mg administered by PCA
Duration of peripheral nerve block From execution of a peripheral nerve block till administration of a first dose of iv morphine, up to 48 hours Time between execution of a peripheral nerve block and the first dose of iv morphine
complications of peripheral nerve blocks at the moment of execution of the block (day 0) and at day 3 postoperatively iv injection, hematoma, infection
passive and active motion range at day 3 postoperatively joint motion in degrees
quadriceps strength at day 3 postoperatively Percentage of strength as compared with the opposite leg
hospital stay from admission to the hospital till discharge, up to 3 days length of hospital stay in days
Morphine consumption in the recovery room From admission till discharge from the recovery room, up to 2 hours consumption in mg
Incidence of pruritus at day 1, day 2 and day 3 postoperatively Presence of pruritus
rest and dynamic pain scores at day 1, day 2 and day 3 postoperatively Visual Analogue scale(VAS), 0-10 where 0 is no pain and 10 is the worst pain imaginable
walking distance at 72h postoperatively walking distance without pain
Trial Locations
- Locations (1)
University Hospital of Lausanne
🇨ðŸ‡Lausanne, Vaud, Switzerland