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



Status:Recruiting
Conditions:Arthritis, Post-Surgical Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:40 - 80
Updated:9/20/2018
Start Date:November 29, 2016
End Date:December 2020
Contact:Erin C Owen, PhD
Email:erin.owen@slocumfoundation.org
Phone:541.868.3232

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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.

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.

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
We found this trial at
1
site
Eugene, Oregon 97401
Principal Investigator: Nicholas L Strasser, MD
Phone: 541-868-3232
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mi
from
Eugene, OR
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