Trials / Completed
CompletedNCT02950558
Anesthesia for Pain After Ankle Fracture Surgery
Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- University of Cincinnati · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture compared to standard of care. Subjects will be followed for one year.
Detailed description
This pilot study will test the hypothesis that prolonged regional peripheral nerve block will reduce development of chronic pain in patients undergoing surgery for ankle fracture. Regional nerve block using local anesthetics delivered by ambulatory pump is used in some types of surgeries but is not routine for ankle fracture patients in our hospitals. Patients will be randomized to standard care (single shot peripheral nerve block prior to surgery) or experimental (the same single shot nerve block, followed by continuous popliteal nerve block with ropivacaine starting just after surgery). The primary outcome will be scores on a validated ankle/foot pain questionnaire that includes questions on function. Subjects will be followed for one year. Secondary outcome will be postoperative opioid use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ropivacaine | Single injection of ropivacaine immediately prior to surgery. |
| PROCEDURE | Nerve block | insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2019-11-14
- Completion
- 2020-06-19
- First posted
- 2016-11-01
- Last updated
- 2021-07-02
- Results posted
- 2021-07-02
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02950558. Inclusion in this directory is not an endorsement.