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

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.

Study Overview

• Status: Unknown
• Conditions: Ankle Arthropathy; Ankle Arthritis
• Intervention / Treatment: Procedure: Intra-articular injection; Procedure: Peripheral nerve block

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Slocum Research & Education Foundation
      • Contact: Michelle Bremer, BS; Phone Number: 5418683217; Email: michelle.bremer@slocumfoundation.org
      • Contact: Erin C Owen, PhD; Phone Number: 541-868-3232; Email: erin.owen@slocumfoundation.org
      • Principal Investigator: Nicholas L Strasser, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: Peripheral nerve block; Pre-operative peripheral nerve block.	Procedure: Peripheral nerve block; Pre-operative peripheral nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and Ankle Ability Measure (FAAM)	Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments.	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.	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.	Up to 3 months post-operatively
Time to narcotic discontinuation	Number of days narcotics were taken for post-operative pain control	Up to 3 months post-operatively

Collaborators and Investigators

• Sponsor: Slocum Research & Education Foundation
• Collaborators: Slocum Center for Orthopedics & Sports Medicine
• Investigators: Principal Investigator: Nicholas L Strasser, MD, Slocum Center for Orthopedics & Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: NLS_TAA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No