Anesthesia for Pain After Ankle Fracture Surgery

Phase 4

Completed

• Conditions: Chronic Pain; Ankle Fracture Surgery; Regional Anesthesia
• Interventions: Drug: Ropivacaine; Procedure: Nerve block

• Registration Number: NCT02950558
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-11-01
• Study Start: 2018-05-29
• Primary Completion: 2019-11-14
• Study Completion: 2020-06-19
• Results First Submitted: 2020-12-11
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Results First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine plus Nerve Block	Nerve block	Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Ropivacaine	Ropivacaine	Single injection of ropivacaine immediately prior to surgery
Ropivacaine plus Nerve Block	Ropivacaine	Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.

Primary Outcome Measures

Name	Time	Method
Pain Score at 12 Months - Experimental Group vs. Control Group	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 Outcome Measures

Name	Time	Method
Pain Score at 2 Weeks - Experimental Group vs. Control Group	at 2 weeks post surgery	Patients will complete Self-Administered Foot and Ankle Questionnaire at 2 weeks post surgery. For this instrument, 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome
Pain Score at 3 Months - Experimental Group vs. Control Group	at 3 months post surgery	Patients will complete Self-Administered Foot and Ankle Questionnaire at 3 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.
Pain Score at 6 Months - Experimental Group vs. Control Group	at 6 months post surgery	Patients will complete Self-Administered Foot and Ankle Questionnaire at 6 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.
Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group	at 1 year post surgery	Incidence of chronic ankle pain diagnoses one year after surgery obtained from the medical record was originally planned but proved difficult to obtain. Here we provide the number of patients with a 12 month Self-Administered Foot and Ankle Questionnaire score lower than 40 at the 12 month time point. For this instrument, 48 = no pain or disability; 0 = maximum pain and disability. Scores of 40 below were interpreted to indicate ongoing ankle pain of significance for pain and function, for example, at least 8 of the 12 questions being scored less than the optimal value of 4. Scores from 40 to 48 were interpreted as indicating normal or near normal function of the affected ankle.

Trial Locations

Locations (2)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

UC Health West Chester Hosptial; 🇺🇸 West Chester, Ohio, United States