Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02242201
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2014-09-13
Brief Title:
Total Hip Arthroplasty THA Lumbar Plexus Verses Periarticular
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Prospective Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine Exparel174 on Patients Undergoing Total Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2018-03
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:
None
Brief Summary:
Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades The purpose of this study was to find a better way to make patients comfortable after their hip surgery Three different ways of providing pain relief were compared a peripheral nerve block in the lower back outside of the spinal space using bupivacaine a numbing medicine or injections around the hip joint with one of two different medicines either Ropivacaine or Liposomal Bupivacaine Exparel
Detailed Description:
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay improved patient comfort and enhanced patient satisfaction that is efficacious and cost-effective This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA
Patients undergoing elective unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained posterior lumbar plexus block PNB periarticular infiltration PAI with ropivacaine ketorolac and epinephrine and PAI with liposomal bupivacaine ketorolac and epinephrine The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study
Patients undergoing elective unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained posterior lumbar plexus block PNB periarticular infiltration PAI with ropivacaine ketorolac and epinephrine and PAI with liposomal bupivacaine ketorolac and epinephrine The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR000135 | NIH | None | httpsreporternihgovquickSearchUL1TR000135 |