Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179641
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-11-30
Brief Title:
Comparison of Two Different Regional Analgesia Techniques for Patients Undergoing Total Knee Arthroplasty
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPACK
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 125 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 375 mg of ropivacaine
During the surgery iv dexamethasone 8 mg iv magnesium sulfate 40 mgkg-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
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 125 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 375 mg of ropivacaine
During the surgery iv dexamethasone 8 mg iv magnesium sulfate 40 mgkg-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None