Anesthesia for Pain After Ankle Fracture Surgery

Chronic Pain Clinical Trial

Official title:

Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950558
• Other study ID #: Zhang2016
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2018
• Est. completion date: June 19, 2020

Study information

• Verified date: June 2021
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 19, 2020
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture Surgery
• Ankle Fractures
• Chronic Pain
• Fractures, Bone
• Regional Anesthesia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	UC Health West Chester Hosptial	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score at 12 Months - Experimental Group vs. Control Group	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.	at 12 months post surgery
Secondary	Pain Score at 2 Weeks - Experimental Group vs. Control Group	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	at 2 weeks post surgery
Secondary	Pain Score at 3 Months - Experimental Group vs. Control Group	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.	at 3 months post surgery
Secondary	Pain Score at 6 Months - Experimental Group vs. Control Group	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.	at 6 months post surgery
Secondary	Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group	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.	at 1 year post surgery