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Anesthesia for Pain After Ankle Fracture Surgery

Primary Purpose

Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Nerve block
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cincinnati Medical Center
  • UC Health West Chester Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ropivacaine

Ropivacaine plus Nerve Block

Arm Description

Single injection of ropivacaine immediately prior to surgery

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
October 4, 2016
Last Updated
June 30, 2021
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02950558
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
June 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
Single injection of ropivacaine immediately prior to surgery
Arm Title
Ropivacaine plus Nerve Block
Arm Type
Experimental
Arm Description
Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Single injection of ropivacaine immediately prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Nerve block
Other Intervention Name(s)
no other name
Intervention Description
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Primary Outcome Measure Information:
Title
Pain Score at 12 Months - Experimental Group vs. Control Group
Description
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.
Time Frame
at 12 months post surgery
Secondary Outcome Measure Information:
Title
Pain Score at 2 Weeks - Experimental Group vs. Control Group
Description
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
Time Frame
at 2 weeks post surgery
Title
Pain Score at 3 Months - Experimental Group vs. Control Group
Description
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.
Time Frame
at 3 months post surgery
Title
Pain Score at 6 Months - Experimental Group vs. Control Group
Description
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.
Time Frame
at 6 months post surgery
Title
Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group
Description
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.
Time Frame
at 1 year post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Ming Zhang, MD, MSc
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45216
Country
United States
Facility Name
UC Health West Chester Hosptial
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Anesthesia for Pain After Ankle Fracture Surgery

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