Predicting, Understanding and Speeding Recovery After TKA

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this research study is to better understand patterns of recovery after Total Knee Arthroplasty (TKA). The study will evaluate how pain, activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate the efficacy of gabapentin versus placebo for improving recovery after surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• Adults scheduled for elective total knee replacement

• American Society of Anesthesiologists physical status 1-3

• Participants must be able to read and write English

Exclusion Criteria:

• Inability to complete questionnaires

• Pregnancy

• Litigation or workers compensation related to joint surgery

• For 250 subjects in primary analysis - taking < 100 mg morphine equivalents/day. For 50 subjects to test gabapentin's effect on pupil diameter - taking >100 mg morphine equivalents/day

• history of Raynaud's disease of the feet

• suffering from a psychotic disorder or a recent psychiatric hospitalization

• history of eye surgery or topical eye medications that would render pupillometry unreliable or would directly affect pupil diameter.

• any disorder that would affect pupil responsivity or prevent accuracy of pupillometry such as movement disorders