Predicting, Understanding and Speeding Recovery After TKA



Status:Recruiting
Conditions:Chronic Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 70
Updated:8/11/2018
Start Date:February 2016
End Date:February 2022
Contact:Regina Curry, RN
Email:recurry@wakehealth.edu
Phone:336-716-4294

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Predicting, Understanding, and Speeding Recovery After Total Knee Arthroplasty

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.

The investigators propose a two-site, longitudinal, double-blind, randomized clinical
intervention study to examine three specific aims:

Aim 1: Characterize the dynamic pain experience, activity, and cognitive response after TKA
and determine patterns of recovery in these domains

Aim 2: Test whether gabapentin alters time course of recovery after TKA in a manner dependent
on its interaction with pre-drug pupil diameter and preferred style in the
catastrophizing-optimism dimension

Aim 3: Test whether gabapentin increases pupil diameter in patients undergoing TKA who are on
high dose opioids preoperatively and to examine whether opioid use moderates the associations
in Aim 1

Primary Hypothesis: Novel variance beyond established associations in recovery from pain
following TKA surgery is accounted for by the interaction between pupil diameter and
Cognitive-Affective (C-A) state, and this interaction predicts efficacy of gabapentin to
speed recovery.

Key secondary hypotheses: Disability, impulsivity, and attentional deficits recover after TKA
surgery follow a log of time pattern, and are predicted by C-A state and its interaction with
pupil diameter. Gabapentin increases resting pupil diameter in patients scheduled for TKA who
are receiving high doses of opioids.

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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: James C Eisenach, MD
Phone: 336-716-4294
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mi
from
Winston-Salem, NC
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