Ankle SurgeryNCT03894098
High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery
A study testing Nerve block in people with Ankle Surgery, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Surgery
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults undergoing elective foot and ankle surgery
- Adults ≥18 years, intact presurgical peripheral sensation based on 5.07 monofilament testing, foot and ankle surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Surgery
- Being tested
- Nerve block
- Keywords
- nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
High ankle nerve block
| Study group | Role | What they receive |
|---|---|---|
| Single shot regional popliteal and saphenous block | Active comparator | Standard of care traditional single shot popliteal / saphenous regional block for acute pain control after elective ankle surgery Receives: Procedure: Nerve block |
| High ankle block | Experimental | High ankle block for acute pain control after elective ankle surgery Receives: Procedure: Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours, 48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start26 Mar 2019
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: Low interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn G. Shi, M.D., Mayo Clinic
- Investigators
- Glenn G Shi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894098
- Sponsor's protocol ID
- 18-002398
- Status last verified
- May 2022
- First submitted
- 27 Mar 2019
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Ankle Block Versus Regional Block for Acute Pain Control After Ankle Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03894098
- Acronym / sponsor ID
- 18-002398
- Conditions
- Ankle Surgery
- Keywords
- nerve block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single shot regional popliteal and saphenous block | Active comparator | Procedure: Nerve blockStandard of care traditional single shot popliteal / saphenous regional block for acute pain control after elective ankle surgery |
| High ankle block | Experimental | Procedure: Nerve blockHigh ankle block for acute pain control after elective ankle surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults undergoing elective foot and ankle surgery
- Adults ≥18 years, intact presurgical peripheral sensation based on 5.07 monofilament testing, foot and ankle surgery
Key exclusion criteria (6 listed)
- Presurgical neurologic discrepancies (peripheral neuropathy, radiculopathy)
- Complex regional pain syndrome
- peripheral nerve surgery
- Surgery above the level of the tibiotalar joint
- Narcotic dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve blockHigh ankle nerve block | Procedure or surgery | High ankle block, Single shot regional popliteal and saphenous block |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ankle Surgery
RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Recruiting
Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery
Gastrocnemius, Ankle Surgery
Recruiting
Sensor Ankle Brace for Special Operations Rehabilitation
Gait, Balance
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn G Shi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Ankle Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: 24 hours, 48 hours, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.