Ankle ArthritisNCT03674905
Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain
A study testing Intra-articular injection and Peripheral nerve block in people with Ankle Arthritis and Ankle Arthropathy, run by Slocum Research & Education Foundation at 1 site in United States.
Trial summary
Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ankle Arthritis, Ankle Arthropathy
- What is being tested?
- Intra-articular injection and Peripheral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to Dec 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 40 - 80 years old
- Patient is having a primary, unilateral TAA
- Patient has signed the current, Institutional Review Board approved informed consent document
Who cannot join
- Patient has untreated endocrine disease
- Patient has uncontrolled diabetes; lab result of hemoglobin A1c level > 8.0 mg/dL
- Patient has significant heart, liver, kidney or respiratory disease
- Patient has peripheral vascular disease
- Patient has active cancer
- Patient has current history of narcotic use beyond that of oral medications
- Patient discharge status is known to be to care facility
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Slocum Research & Education Foundation
Eugene, Oregon, 97401
Erin C Owen, PhD, 541-868-3232, erin.owen@slocumfoundation.org
Michelle Bremer, BS, 5418683217, michelle.bremer@slocumfoundation.org
About this study
Official title: Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.
Read the detailed description
This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis.
Patients will be randomized to receive one of the following interventions for pain control in the operating room:
- Intra-articular Injection
- Preoperative Peripheral Nerve Block:
The study aims are:
- Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block.
- Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires
Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.
- Conditions
- Ankle Arthritis, Ankle Arthropathy
- Being tested
- Intra-articular injection, Peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injectionProcedure or surgery
Intra-articular injection at the completion of TAA procedure.
Peripheral nerve blockProcedure or surgery
Pre-operative peripheral nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular injection | Other | Intra-articular injection at the completion of TAA procedure. Receives: Procedure: Intra-articular injection |
| Peripheral nerve block | Other | Pre-operative peripheral nerve block. Receives: Procedure: Peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total narcotic use in morphine equivalents
Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.
Measured: Up to 3 months post-operatively
Self-reported pain captured with a visual analog pain scale
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)
Measured: Up to 3 months post-operatively
Secondary outcomes (4)
Foot and Ankle Ability Measure (FAAM)
Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments.
Measured: Up to 3 months post-operatively
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score
Grades ankle, subtalar, talonavicular, and calcaneocuboid joint levels in terms of pain (40 points), function (50 points), and alignment (10 points); 100 points possible sub-scores are summed, higher indicates better outcome.
Measured: Up to 3 months post-operatively
Veterans Rand (VR) 36 item Health Survey
VR-36 Consists of select items from eight concepts of health in the VR-36, measuring health-related quality of life, and differences in disease burden.
Measured: Up to 3 months post-operatively
Time to narcotic discontinuation
Number of days narcotics were taken for post-operative pain control
Measured: Up to 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start29 Nov 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slocum Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Slocum Center for Orthopedics and Sports Medicine
- Responsible party
- Principal investigator, Nicholas Strasser, Slocum Research & Education Foundation
- Investigators
- Nicholas L Strasser, MD, Principal investigator, Slocum Center for Orthopedics and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674905
- Sponsor's protocol ID
- NLS_TAA1
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 18 Sep 2018
- 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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03674905
- Acronym / sponsor ID
- NLS_TAA1
- Conditions
- Ankle Arthritis, Ankle Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Slocum Research & Education FoundationUniversity, hospital or other
- Collaborators
- Slocum Center for Orthopedics and Sports Medicine
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Sep 2018 (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.
Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.
Detailed description
This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis.
Patients will be randomized to receive one of the following interventions for pain control in the operating room:
- Intra-articular Injection
- Preoperative Peripheral Nerve Block:
The study aims are:
- Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block.
- Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires
Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular injection | Other | Procedure: Intra-articular injectionIntra-articular injection at the completion of TAA procedure. |
| Peripheral nerve block | Other | Procedure: Peripheral nerve blockPre-operative peripheral nerve block. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 40 - 80 years old
- Patient is having a primary, unilateral TAA
- Patient has signed the current, Institutional Review Board approved informed consent document
Key exclusion criteria (7 listed)
- Patient has untreated endocrine disease
- Patient has uncontrolled diabetes; lab result of hemoglobin A1c level > 8.0 mg/dL
- Patient has significant heart, liver, kidney or respiratory disease
- Patient has peripheral vascular disease
- Patient has active cancer
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 |
|---|---|---|
| Intra-articular injectionIntra-articular injection at the completion of TAA procedure. | Procedure or surgery | Intra-articular injection |
| Peripheral nerve blockPre-operative peripheral nerve block. | Procedure or surgery | Peripheral nerve block |
Primary outcome
Total narcotic use in morphine equivalents
Time frame: Up to 3 months post-operatively
Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.
Self-reported pain captured with a visual analog pain scale
Time frame: Up to 3 months post-operatively
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)
4 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: Up to 3 months post-operatively
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score
Time frame: Up to 3 months post-operatively
Veterans Rand (VR) 36 item Health Survey
Time frame: Up to 3 months post-operatively
Time to narcotic discontinuation
Time frame: Up to 3 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Nicholas L Strasser, MD principal investigator
Slocum Center for Orthopedics and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular injection and Peripheral nerve block in people with Ankle Arthritis and Ankle Arthropathy, run by Slocum Research & Education Foundation 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin C Owen, PhD (541.868.3232, erin.owen@slocumfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total narcotic use in morphine equivalents (time frame: Up to 3 months post-operatively). The study lists 2 primary outcomes in all. 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 18 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.