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

Ankle Arthritis Clinical Trial

Official title:

Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03674905
• Other study ID #: NLS_TAA1
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Slocum Research & Education Foundation
• Contact: Erin C Owen, PhD
• Phone: 541.868.3232
• Email: erin.owen[@]slocumfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Arthritis
• Ankle Arthropathy
• Joint Diseases
• Pain, Postoperative

Intervention

Procedure:
• Intra-articular injection
Intra-articular injection at the completion of TAA procedure.
• Peripheral nerve block
Pre-operative peripheral nerve block.

Locations

Country	Name	City	State
United States	Slocum Research & Education Foundation	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Slocum Research & Education Foundation	Slocum Center for Orthopedics & Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time to narcotic discontinuation	Number of days narcotics were taken for post-operative pain control	Up to 3 months post-operatively