Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-11 @ 5:02 PM
Study NCT ID:
NCT03674905
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain
Sponsor:
Slocum Research & Education Foundation
Organization:
Study Overview
Official Title:
Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: