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

Primary Purpose

Ankle Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve block
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Surgery focused on measuring nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single shot regional popliteal and saphenous block

High ankle block

Arm Description

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

High ankle block for acute pain control after elective ankle surgery

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 27, 2019
Last Updated
May 25, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03894098
Brief Title
High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery
Official Title
High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Low interest.
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Surgery
Keywords
nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single shot regional popliteal and saphenous block
Arm Type
Active Comparator
Arm Description
Standard of care traditional single shot popliteal / saphenous regional block for acute pain control after elective ankle surgery
Arm Title
High ankle block
Arm Type
Experimental
Arm Description
High ankle block for acute pain control after elective ankle surgery
Intervention Type
Procedure
Intervention Name(s)
Nerve block
Intervention Description
High ankle nerve block
Primary Outcome Measure Information:
Title
Change in pain score
Description
Measured using Defense and Veterans Pain Scale (lowest score of 0 = No pain and 10 = As bad as it could be, nothing else matters)
Time Frame
24 hours, 48 hours, 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn G Shi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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