Predicting, Understanding and Speeding Recovery After TKA

  • days left to enroll
  • participants needed
  • sponsor
    Wake Forest University Health Sciences
Updated on 23 February 2022
total knee replacement


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.

Condition Pain, Total Knee Replacement
Treatment Placebo, Gabapentin
Clinical Study IdentifierNCT02685735
SponsorWake Forest University Health Sciences
Last Modified on23 February 2022


Yes No Not Sure

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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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