Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine
- Conditions
- Chronic Pain
- Sponsor
- University of Cincinnati
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Pain Score at 12 Months - Experimental Group vs. Control Group
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Jun-ming Zhang
Professor of Anesthesia
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •Referred for surgery for open reduction and internal fixation for ankle fracture
Exclusion Criteria
- •Unable to give informed consent in English
- •Unable to complete surveys in English
- •Unable to understand instructions for using pump in English
- •Unavailable for followup
- •Polytrauma; undergoing other surgeries or having other orthopedic injuries related to the precipitating cause of the ankle fracture
- •Infection
- •Peripheral vascular disease
- •Currently undergoing chemotherapy
- •Pregnancy
- •Currently lactating
Arms & Interventions
Ropivacaine
Single injection of ropivacaine immediately prior to surgery
Intervention: Ropivacaine
Ropivacaine plus Nerve Block
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Intervention: Ropivacaine
Ropivacaine plus Nerve Block
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Intervention: Nerve block
Outcomes
Primary Outcomes
Pain Score at 12 Months - Experimental Group vs. Control Group
Time Frame: at 12 months post surgery
Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.
Secondary Outcomes
- Pain Score at 2 Weeks - Experimental Group vs. Control Group(at 2 weeks post surgery)
- Pain Score at 3 Months - Experimental Group vs. Control Group(at 3 months post surgery)
- Pain Score at 6 Months - Experimental Group vs. Control Group(at 6 months post surgery)
- Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group(at 1 year post surgery)