Trials / Completed
CompletedNCT02223364
Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peripheral nerve blocks with Bupivacaine | Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve. |
| DRUG | Intra articular injection with Ropivacaine | Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg. |
| DRUG | Intra articular injection with liposomal bupivacaine | Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-08-22
- Last updated
- 2017-08-31
- Results posted
- 2017-08-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02223364. Inclusion in this directory is not an endorsement.