Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653621
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement a Prospective Single-center Simple Randomized Active-controlled Single-blind 2x2 Factorial Design Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA total knee replacement patientsThe main questions answered are
1 Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement
2 Which block methodFemoral triangle block or adductor block combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery
investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block
Participants will
1 Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance
2 Undergo total knee replacement surgery under spinal anesthesia
3 Follow-up within 72 hours after surgery opioid consumption NRS score PCAPatient controlled analgesiaPCA data first postoperative remedial analgesia time quadriceps muscle strength and complications were recorded
1 Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement
2 Which block methodFemoral triangle block or adductor block combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery
investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block
Participants will
1 Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance
2 Undergo total knee replacement surgery under spinal anesthesia
3 Follow-up within 72 hours after surgery opioid consumption NRS score PCAPatient controlled analgesiaPCA data first postoperative remedial analgesia time quadriceps muscle strength and complications were recorded
Detailed Description:
The patients received femoral triangle block plus iPACKinfiltration between popliteal artery and capsule of knee block or adductor canal block plus iPACK block during induction
The local anesthetic formulation was bupivacaine 075 bupivacaine hydrochloride 10ml normal saline 20ml or bupivacaine liposome 075 bupivacaine hydrochloride 10ml bupivacaine liposome 20ml266mg
The local anesthetic formulation was bupivacaine 075 bupivacaine hydrochloride 10ml normal saline 20ml or bupivacaine liposome 075 bupivacaine hydrochloride 10ml bupivacaine liposome 20ml266mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None