Clinical trial NCT02950558: Anesthesia for Pain After Ankle Fracture Surgery
Official title: Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Ankle Fracture Surgery
Regional Anesthesia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Diabetes
* Currently undergoing chemotherapy
* Pregnancy
* Currently lactating
* Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs
* Severe renal impairment (Class 3 or worse kidney disease)
* Liver disease (cirrhosis or liver failure)
* Prior allergic reaction to any type of local anesthetic
* Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic doses started because of hospital admission are not an exclusion)
* Currently taking antidepressants or other psychiatric medications
* Single shot local nerve block prior to surgery was ineffective
* Selected for neuraxial anesthesia rather than general anesthesia for the open reduction surgery
* Already receiving chronic analgesic therapy for a separate chronic pain condition

Primary outcomes:
measure: Pain Score at 12 Months - Experimental Group vs. Control Group
timeFrame: at 12 months post surgery
Secondary outcomes:
measure: Pain Score at 2 Weeks - Experimental Group vs. Control Group
timeFrame: at 2 weeks post surgery
measure: Pain Score at 3 Months - Experimental Group vs. Control Group
timeFrame: at 3 months post surgery
measure: Pain Score at 6 Months - Experimental Group vs. Control Group
timeFrame: at 6 months post surgery
measure: Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group
timeFrame: at 1 year post surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: West Chester
country: United States
facility: UC Health West Chester Hosptial
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jun-Ming Zhang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: