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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03894098
Other study ID # 18-002398
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 26, 2019
Est. completion date May 24, 2022

Study information

Verified date May 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 24, 2022
Est. primary completion date May 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nerve block
High ankle nerve block

Locations

Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01229696 - Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia Phase 4
Completed NCT01049906 - Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery N/A
Terminated NCT05354791 - Pre-post Spinal Popliteal Block
Enrolling by invitation NCT06465992 - Liposomal Bupivacaine With Dexamethasone for Foot Surgery Phase 4
Completed NCT05368012 - MIDCAB (Mid-Calf Block) for Foot Surgery Phase 4
Enrolling by invitation NCT04575688 - Periarticular Injection Versus Popliteal Block Phase 4
Completed NCT04134962 - Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
Enrolling by invitation NCT04872322 - Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery Phase 3

External Links