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NCT Number: NCT02950558

Anesthesia for 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.

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Key information

Conditions

Chronic Pain Ankle Fracture Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Regional Anesthesia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Single injection of ropivacaine immediately prior to surgery.

Other names: Naropin

Nerve Block

Procedure

insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.

Other names: no other name

Primary outcomes

  1. Pain Score at 12 Months - Experimental Group vs. Control Group

    Time frame: 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 outcomes

  1. Pain Score at 2 Weeks - Experimental Group vs. Control Group

    Time frame: 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

  2. Pain Score at 3 Months - Experimental Group vs. Control Group

    Time frame: 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.

  3. Pain Score at 6 Months - Experimental Group vs. Control Group

    Time frame: 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.

  4. Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 1, 2016
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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