Recruiting

Intra-Articular Injection & Peripheral Nerve Block

Sponsor:

Slocum Research & Education Foundation

Code:

NCT03674905

Conditions

Ankle Arthritis

Ankle Arthropathy

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Intra-articular injection

Peripheral nerve block

Study Details

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.

Conditions

Ankle Arthritis

Ankle Arthropathy

Study ID

NCT03674905

Start date

Nov 29, 2016

Status verified date

Sep, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intra-articular injection

Intra-articular injection at the completion of TAA procedure.

other: Peripheral nerve block

Pre-operative peripheral nerve block.

Interventions

Intra-articular injection

Intra-articular injection at the completion of TAA procedure.

Peripheral nerve block

Pre-operative peripheral nerve block.

Primary outcome measure

  • Total narcotic use in morphine equivalents [ Time Frame: Up to 3 months post-operatively ]
  • Self-reported pain captured with a visual analog pain scale [ Time Frame: Up to 3 months post-operatively ]

Central Contacts and Locations

Central contacts

Erin C Owen, PhD

541.868.3232erin.owen@slocumfoundation.org

Michelle Bremer, BS

5418683217michelle.bremer@slocumfoundation.org

Locations

Slocum Research & Education Foundation

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Erin C Owen, PhD

541-868-3232erin.owen@slocumfoundation.org

Michelle Bremer, BS

5418683217michelle.bremer@slocumfoundation.org

Principal Investigator:

Nicholas L Strasser, MD

More Information

Sponsor

Slocum Research & Education Foundation

Last update posted

Sep 18, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Slocum Research & Education Foundation on 2018-09-18.