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Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain

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ClinicalTrials.gov Identifier: NCT03674905
Recruitment Status : Unknown
Verified September 2018 by Nicholas Strasser, Slocum Research & Education Foundation.
Recruitment status was:  Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Slocum Center for Orthopedics & Sports Medicine
Information provided by (Responsible Party):
Nicholas Strasser, Slocum Research & Education Foundation

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Ankle Arthritis Ankle Arthropathy Procedure: Intra-articular injection Procedure: Peripheral nerve block Not Applicable

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:

  1. Intra-articular Injection
  2. 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Intra-articular injection
Intra-articular injection at the completion of TAA procedure.
 Procedure: Intra-articular injection
Intra-articular injection at the completion of TAA procedure.
Peripheral nerve block
Pre-operative peripheral nerve block.
 Procedure: Peripheral nerve block
Pre-operative peripheral nerve block.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. Foot and Ankle Ability Measure (FAAM) [ Time Frame: Up to 3 months post-operatively ]
    Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments.

  2. American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score [ Time Frame: Up to 3 months post-operatively ]
    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.

  3. Veterans Rand (VR) 36 item Health Survey [ Time Frame: Up to 3 months post-operatively ]
    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.

  4. Time to narcotic discontinuation [ Time Frame: Up to 3 months post-operatively ]
    Number of days narcotics were taken for post-operative pain control


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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): NCT03674905


Contacts
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Contact: Erin C Owen, PhD 541.868.3232 erin.owen@slocumfoundation.org
Contact: Michelle Bremer, BS 5418683217 michelle.bremer@slocumfoundation.org

Locations
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United States, Oregon
Slocum Research & Education Foundation Recruiting
Eugene, Oregon, United States, 97401
Contact: Erin C Owen, PhD    541-868-3232    erin.owen@slocumfoundation.org   
Contact: Michelle Bremer, BS    5418683217    michelle.bremer@slocumfoundation.org   
Principal Investigator: Nicholas L Strasser, MD         
Sponsors and Collaborators
Slocum Research & Education Foundation
Slocum Center for Orthopedics & Sports Medicine
Investigators
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Principal Investigator: Nicholas L Strasser, MD Slocum Center for Orthopedics & Sports Medicine
More Information
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Responsible Party: Nicholas Strasser, Principal Investigator, Slocum Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03674905    
Other Study ID Numbers: NLS_TAA1
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations