Anesthesia for Pain After Ankle Fracture Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Regional Anesthesia; Ankle Fracture Surgery
• Intervention / Treatment: Drug: Ropivacaine; Procedure: Nerve block

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45216
      • University of Cincinnati Medical Center
    • West Chester, Ohio, United States, 45069
      • UC Health West Chester Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine; Single injection of ropivacaine immediately prior to surgery	Drug: Ropivacaine; Single injection of ropivacaine immediately prior to surgery.; Other Names: Naropin
Experimental: Ropivacaine plus Nerve Block; Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.	Drug: Ropivacaine; Single injection of ropivacaine immediately prior to surgery.; Other Names: Naropin; Procedure: Nerve block; insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Jun-Ming Zhang, MD, MSc, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Chronic Pain; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Zhang2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No