Chronic PainPhase 4NCT02950558

Anesthesia for Pain After Ankle Fracture Surgery

A Phase 4 study testing Ropivacaine and Nerve block in people with Chronic Pain and Ankle Fracture Surgery, run by University of Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia
What is being tested?: Ropivacaine and Nerve block
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: 29 May 2018to 19 Jun 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia
Being tested: Ropivacaine, Nerve block
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RopivacaineDrug
Also called Naropin
Single injection of ropivacaine immediately prior to surgery.
Nerve blockProcedure or surgery
Also called no other name
insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.

Study groups in NCT02950558
Study group	Role	What they receive
Ropivacaine	Active comparator	Single injection of ropivacaine immediately prior to surgery Receives: Drug: Ropivacaine
Ropivacaine plus Nerve Block	Experimental	Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Receives: Drug: Ropivacaine; Procedure: Nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at 12 months post surgery

Secondary outcomes (4)

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 1 year post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201819 Jun 2020

First posted1 Nov 2016 (estimated)
Study start29 May 2018
Primary completion14 Nov 2019
Study completion19 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02950558
Sponsor's protocol ID: Zhang2016
Status last verified: Jun 2021
First submitted: 4 Oct 2016
Last updated: 2 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
ClinicalTrials.gov ID: NCT02950558
Acronym / sponsor ID: Zhang2016
Conditions: Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Study start: 29 May 2018 (actual)
Primary completion: 14 Nov 2019 (actual)
Study completion: 19 Jun 2020 (actual)
First posted: 1 Nov 2016 (estimated)
Results: Posted 2 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ropivacaine	Active comparator	Drug: RopivacaineSingle injection of ropivacaine immediately prior to surgery
Ropivacaine plus Nerve Block	Experimental	Drug: Ropivacaine, Procedure: Nerve blockSingle injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RopivacaineAlso: NaropinSingle injection of ropivacaine immediately prior to surgery.	Drug	Ropivacaine, Ropivacaine plus Nerve Block
Nerve blockAlso: no other nameinsertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.	Procedure or surgery	Ropivacaine plus Nerve Block

Primary outcome

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.

4 secondary outcomes

Pain Score at 2 Weeks - Experimental Group vs. Control Group
Time frame: at 2 weeks post surgery
Pain Score at 3 Months - Experimental Group vs. Control Group
Time frame: at 3 months post surgery
Pain Score at 6 Months - Experimental Group vs. Control Group
Time frame: at 6 months post surgery
Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group
Time frame: at 1 year post surgery

Results and safety

Results posted to the registry on 2 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care	8	6
Ropivacaine Pump	6	6

Primary outcome: Pain Score at 12 Months - Experimental Group vs. Control Group

Time frame: at 12 months post surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Standard Care n = 6	Ropivacaine Pump n = 6
Value	36.33 (9.543)	44.00 (1.414)

Standard Care vs Ropivacaine Pump: p = 0.1269, Wilcoxon (Mann-Whitney)

Population analysed: 2 subjects in standard care group were lost to follow-up and did not complete 12 month questionnaire but their questionnaires from earlier time points were included in the analyses.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Ropivacaine Pump	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jun-Ming Zhang, MD, MSc principal investigator

University of Cincinnati

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine and Nerve block in people with Chronic Pain and Ankle Fracture Surgery, run by University of Cincinnati at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score at 12 Months - Experimental Group vs. Control Group (time frame: at 12 months post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02950558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.