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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ankle Arthritis Ankle Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intra-articular injection

Intra-articular injection at the completion of TAA procedure.

Group Type OTHER

Intra-articular injection

Intervention Type PROCEDURE

Intra-articular injection at the completion of TAA procedure.

Peripheral nerve block

Pre-operative peripheral nerve block.

Group Type OTHER

Peripheral nerve block

Intervention Type PROCEDURE

Pre-operative peripheral nerve block.

Interventions

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Intra-articular injection

Intra-articular injection at the completion of TAA procedure.

Intervention Type PROCEDURE

Peripheral nerve block

Pre-operative peripheral nerve block.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No