Clinical trial NCT03674905: Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain
Official title: Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Arthritis
Ankle Arthropathy
Lead sponsor: Slocum Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: Slocum Center for Orthopedics and Sports Medicine
First posted: 2018-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total narcotic use in morphine equivalents
timeFrame: Up to 3 months post-operatively
measure: Self-reported pain captured with a visual analog pain scale
timeFrame: Up to 3 months post-operatively
Secondary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Up to 3 months post-operatively
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score
timeFrame: Up to 3 months post-operatively
measure: Veterans Rand (VR) 36 item Health Survey
timeFrame: Up to 3 months post-operatively
measure: Time to narcotic discontinuation
timeFrame: Up to 3 months post-operatively
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Slocum Research & Education Foundation
state: Oregon
Study officials:
affiliation: Slocum Center for Orthopedics and Sports Medicine
name: Nicholas L Strasser, MD
role: PRINCIPAL_INVESTIGATOR
References: