NCT03674905

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Slocum Research & Education Foundation · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ankle Arthritis
• Ankle Arthropathy

Interventions

Type	Name	Description
PROCEDURE	Intra-articular injection	Intra-articular injection at the completion of TAA procedure.
PROCEDURE	Peripheral nerve block	Pre-operative peripheral nerve block.

Timeline

• Start date: 2016-11-29
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2018-09-18
• Last updated: 2018-09-18

Locations

1 site across 1 country: United States