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

Primary Purpose

Ankle Arthritis, Ankle Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-articular injection
Peripheral nerve block
Sponsored by
Slocum Research & Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Arthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Slocum Research & Education FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intra-articular injection

Peripheral nerve block

Arm Description

Intra-articular injection at the completion of TAA procedure.

Pre-operative peripheral nerve block.

Outcomes

Primary Outcome Measures

Total narcotic use in morphine equivalents
Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.
Self-reported pain captured with a visual analog pain scale
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)

Secondary Outcome Measures

Foot and Ankle Ability Measure (FAAM)
Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments.
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.
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.
Time to narcotic discontinuation
Number of days narcotics were taken for post-operative pain control

Full Information

First Posted
September 11, 2018
Last Updated
September 14, 2018
Sponsor
Slocum Research & Education Foundation
Collaborators
Slocum Center for Orthopedics & Sports Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03674905
Brief Title
Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain
Official Title
Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Slocum Research & Education Foundation
Collaborators
Slocum Center for Orthopedics & Sports Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Arthritis, Ankle Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular injection
Arm Type
Other
Arm Description
Intra-articular injection at the completion of TAA procedure.
Arm Title
Peripheral nerve block
Arm Type
Other
Arm Description
Pre-operative peripheral nerve block.
Intervention Type
Procedure
Intervention Name(s)
Intra-articular injection
Intervention Description
Intra-articular injection at the completion of TAA procedure.
Intervention Type
Procedure
Intervention Name(s)
Peripheral nerve block
Intervention Description
Pre-operative peripheral nerve block.
Primary Outcome Measure Information:
Title
Total narcotic use in morphine equivalents
Description
Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.
Time Frame
Up to 3 months post-operatively
Title
Self-reported pain captured with a visual analog pain scale
Description
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)
Time Frame
Up to 3 months post-operatively
Secondary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM)
Description
Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments.
Time Frame
Up to 3 months post-operatively
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score
Description
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.
Time Frame
Up to 3 months post-operatively
Title
Veterans Rand (VR) 36 item Health Survey
Description
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.
Time Frame
Up to 3 months post-operatively
Title
Time to narcotic discontinuation
Description
Number of days narcotics were taken for post-operative pain control
Time Frame
Up to 3 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin C Owen, PhD
Phone
541.868.3232
Email
erin.owen@slocumfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Bremer, BS
Phone
5418683217
Email
michelle.bremer@slocumfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas L Strasser, MD
Organizational Affiliation
Slocum Center for Orthopedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slocum Research & Education Foundation
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin C Owen, PhD
Phone
541-868-3232
Email
erin.owen@slocumfoundation.org
First Name & Middle Initial & Last Name & Degree
Michelle Bremer, BS
Phone
5418683217
Email
michelle.bremer@slocumfoundation.org
First Name & Middle Initial & Last Name & Degree
Nicholas L Strasser, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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