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

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ClinicalTrials.gov Identifier: NCT03894098
Recruitment Status : Withdrawn (Low interest.)
First Posted : March 28, 2019
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Glenn G. Shi, M.D., Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ankle Surgery Procedure: Nerve block Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery: A Prospective Randomized Controlled Study
Actual Study Start Date : March 26, 2019
Actual Primary Completion Date : May 24, 2022
Actual Study Completion Date : May 24, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Procedure: Nerve block
High ankle nerve block
Experimental: High ankle block
High ankle block for acute pain control after elective ankle surgery
 Procedure: Nerve block
High ankle nerve block


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain score [ Time Frame: 24 hours, 48 hours, 72 hours ]
    Measured using Defense and Veterans Pain Scale (lowest score of 0 = No pain and 10 = As bad as it could be, nothing else matters)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894098


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Glenn G Shi, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Glenn G. Shi, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03894098    
Other Study ID Numbers: 18-002398
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenn G. Shi, M.D., Mayo Clinic:
nerve block
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations