Pain, Postoperative Clinical Trial
Official title:
Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.
NCT number | NCT03001453 |
Other study ID # | AHI-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | March 2016 |
Verified date | June 2018 |
Source | American Hip Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.
Status | Completed |
Enrollment | 107 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled to undergo primary unilateral total hip replacement - Patients diagnosed with hip osteoarthritis - Patients failed to improve with conservative measures - Patients willing and able to sign informed consent Exclusion Criteria: - Revision total hip replacement - Bilateral total hip replacement - Birmingham hip resurfacing - Patients with hepatic/kidney disease - Patients with a known allergy to bupivacaine or other local anesthetics |
Country | Name | City | State |
---|---|---|---|
United States | Adventist Hinsdale Hospital | Hinsdale | Illinois |
United States | American Hip Institute | Westmont | Illinois |
Lead Sponsor | Collaborator |
---|---|
American Hip Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Morphine Equivalent Consumption | All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams. | 72 hours postoperation, divided into six 12-hour periods | |
Primary | Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score | Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval. | 72 hours post-operation, divided into six 12-hour periods | |
Primary | Time to Ambulation More Than 20 Feet (in Hours) | The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded. | from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first | |
Primary | Length of Stay (LOS, in Days) | From time of surgery until patient is discharged, an average of 1.5 days. | ||
Primary | Number of Patients That Experienced a Fall | 72 hours postoperation |
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