Anesthesia for Pain After Ankle Fracture Surgery

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Ankle Fracture Surgery; Chronic Pain; Regional Anesthesia

Treatments: Drug: Ropivacaine; Procedure: Nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT02950558

Zhang2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Ropivacaine

Active Comparator group

Description:

Single injection of ropivacaine immediately prior to surgery

Treatment:

Drug: Ropivacaine

Ropivacaine plus Nerve Block

Experimental group

Description:

Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.

Treatment:

Procedure: Nerve block

Drug: Ropivacaine