NCT03894098

Brief Summary

Researchers are trying to determine if a high ankle block during ankle surgery provides the same pain relief as the standard regional block.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

3.2 years

First QC Date

March 27, 2019

Last Update Submit

May 25, 2022

Conditions

Ankle Surgery

Keywords

nerve block

Outcome Measures

Primary Outcomes (1)

  • Change in pain score

    Measured using Defense and Veterans Pain Scale (lowest score of 0 = No pain and 10 = As bad as it could be, nothing else matters)

    24 hours, 48 hours, 72 hours

Study Arms (2)

Single shot regional popliteal and saphenous block

ACTIVE COMPARATOR

Standard of care traditional single shot popliteal / saphenous regional block for acute pain control after elective ankle surgery

Procedure: Nerve block

High ankle block

EXPERIMENTAL

High ankle block for acute pain control after elective ankle surgery

Procedure: Nerve block

Interventions

Nerve blockPROCEDURE

High ankle nerve block

High ankle blockSingle shot regional popliteal and saphenous block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing elective foot and ankle surgery
  • Adults ≥18 years, intact presurgical peripheral sensation based on 5.07 monofilament testing, foot and ankle surgery

You may not qualify if:

  • Presurgical neurologic discrepancies (peripheral neuropathy, radiculopathy)
  • Complex regional pain syndrome
  • peripheral nerve surgery
  • Surgery above the level of the tibiotalar joint
  • Narcotic dependency
  • Anyone unable to receive a high ankle block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Glenn G Shi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 28, 2019

Study Start

March 26, 2019

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)