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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
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.
University Hospital of Lausanne
Lausanne, Canton of Vaud, Switzerland
RECRUITINGTotal iv morphine consumption
consumption in mg
Time frame: 24 hours postoperatively
Morphine consumption in the recovery room
consumption in mg
Time frame: From admission till discharge from the recovery room, up to 2 hours
PCA administered morphine consumption
consumption in mg administered by PCA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at day 1, day 2 and day 3 postoperatively
Incidence of pruritus
Presence of pruritus
Time frame: at day 1, day 2 and day 3 postoperatively
peroneal nerve block
presence of peroneal nerve block
Time frame: at day 1, day 2 and day 3 postoperatively
complications of peripheral nerve blocks
iv injection, hematoma, infection
Time frame: at the moment of execution of the block (day 0) and at day 3 postoperatively
passive and active motion range
joint motion in degrees
Time frame: at day 3 postoperatively
quadriceps strength
Percentage of strength as compared with the opposite leg
Time frame: at day 3 postoperatively
walking distance
walking distance without pain
Time frame: at 72h postoperatively
hospital stay
length of hospital stay in days
Time frame: from admission to the hospital till discharge, up to 3 days
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