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

NCT03674905 | Unknown

• 1 other identifier: NLS_TAA1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Arthritis; Ankle Arthropathy

Outcome Measures

Primary Outcomes (2)

• Total narcotic use in morphine equivalents

  Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.

  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)

  Up to 3 months post-operatively

Secondary Outcomes (4)

• Foot and Ankle Ability Measure (FAAM)

  Up to 3 months post-operatively

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score

  Up to 3 months post-operatively

• Veterans Rand (VR) 36 item Health Survey

  Up to 3 months post-operatively

• Time to narcotic discontinuation

  Up to 3 months post-operatively

Study Arms (2)

Intra-articular injection

OTHER

Intra-articular injection at the completion of TAA procedure.

Procedure: Intra-articular injection

Peripheral nerve block

OTHER

Pre-operative peripheral nerve block.

Procedure: Peripheral nerve block

Interventions

Intra-articular injection PROCEDURE

Intra-articular injection at the completion of TAA procedure.

Intra-articular injection

Peripheral nerve block PROCEDURE

Pre-operative peripheral nerve block.

Peripheral nerve block

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Slocum Research & Education Foundation: lead
• Slocum Center for Orthopedics and Sports Medicine: collaborator

Study Sites (1)

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

RECRUITING

MeSH Terms

Interventions

Injections, Intra-Articular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Nicholas L Strasser, MD

  Slocum Center for Orthopedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin C Owen, PhD

CONTACT

541.868.3232; erin.owen@slocumfoundation.org

Michelle Bremer, BS

CONTACT

5418683217; michelle.bremer@slocumfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 18, 2018
• Study Start: November 29, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)