High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery

NCT ID: NCT03894098

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2022-05-24

Brief Summary

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

Detailed Description

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Participants scheduled for elective ankle surgery will be randomized to have either a high ankle nerve block or a regional nerve block. Pain levels after surgery will be assessed to determine whether one type of block provides better pain relief compared to the other.

Conditions

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Ankle Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single shot regional popliteal and saphenous block

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

Group Type ACTIVE_COMPARATOR

Nerve block

Intervention Type PROCEDURE

High ankle nerve block

High ankle block

High ankle block for acute pain control after elective ankle surgery

Group Type EXPERIMENTAL

Nerve block

Intervention Type PROCEDURE

High ankle nerve block

Interventions

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Nerve block

High ankle nerve block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Glenn G. Shi, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glenn G Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-002398

Identifier Type: -

Identifier Source: org_study_id

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