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

Slocum Research & Education Foundation

Status: Unknown

Conditions: Ankle Arthropathy; Ankle Arthritis

Treatments: Procedure: Intra-articular injection; Procedure: Peripheral nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT03674905

NLS_TAA1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intra-articular injection

Other group

Description:

Intra-articular injection at the completion of TAA procedure.

Treatment:

Procedure: Intra-articular injection

Peripheral nerve block

Other group

Description:

Pre-operative peripheral nerve block.

Treatment:

Procedure: Peripheral nerve block