Anesthesia for Pain After Ankle Fracture Surgery

NCT02950558 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Zhang2016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Ankle Fracture Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  at 2 weeks post surgery

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

  at 3 months post surgery

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

  at 6 months post surgery

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

  at 1 year post surgery

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Single injection of ropivacaine immediately prior to surgery

Drug: Ropivacaine

Ropivacaine plus Nerve Block

EXPERIMENTAL

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

Drug: Ropivacaine; Procedure: Nerve block

Interventions

Ropivacaine DRUG

Single injection of ropivacaine immediately prior to surgery.

Also known as: Naropin

Ropivacaine; Ropivacaine plus Nerve Block

Nerve block PROCEDURE

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

Also known as: no other name

Ropivacaine plus Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for surgery for open reduction and internal fixation for ankle fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45216, United States

Location

UC Health West Chester Hosptial

West Chester, Ohio, 45069, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Ropivacaine; Nerve Block

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

A problem encountered was that only 1 of the 6 subjects in the pump group received the full 5 days of treatment. The others discontinued using the pump early, primarily due to problems with catheter dislodgement/leakage. As specified in the statistical analysis plan, these subjects were all analyzed with intent-to-treat protocol and are included in the pump group data presented. Also, by chance, the distribution of males and females between the group was quite uneven.

Results Point of Contact

• Title: Jun-Ming Zhang, MD, MSc
• Organization: University of Cincinnati

jun-ming.zhang@uc.edu

5135582427

Study Officials

• Jun-Ming Zhang, MD, MSc

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: November 1, 2016
• Study Start: May 29, 2018
• Primary Completion: November 14, 2019
• Study Completion: June 19, 2020
• Last Updated: July 2, 2021
• Results First Posted: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)