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

High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery: A Prospective Randomized Controlled Study

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

Study Overview

• Status: Withdrawn
• Conditions: Ankle Surgery
• Intervention / Treatment: Procedure: Nerve 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Glenn G Shi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 18-002398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No