Clinical trial NCT02685735: Predicting, Understanding and Speeding Recovery After TKA
Official title: Predicting, Understanding, and Speeding Recovery After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Total Knee Replacement
Total Hip Replacement
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2016-02-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this research study is to better understand patterns of recovery after Total Knee Arthroplasty (TKA) amd Total Hip Replacement (THA). 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.

Detailed description: 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 or THA 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 or THA 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 or THA 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 or THA 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.

Eligibility criteria: Inclusion Criteria:

* Adults scheduled for elective total knee or hip 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

Primary outcomes:
measure: Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept
timeFrame: The first day after hospital discharge up to 5 days post surgery
measure: Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo-- Slope
timeFrame: Postoperative Day 1 through Postoperative Day 60
measure: Effect Pupil Diameter, Catastrophizing-optimism Construct, and Gabapentin on Model Fit of the Trajectory of Change in Worst Daily Pain After Surgery
timeFrame: Postoperative Day 1 through Postoperative Day 60
Secondary outcomes:
measure: Wisconsin Card Sort Task
timeFrame: Preoperative, 2 months after surgery, 6 months after surgery
measure: Iowa Gambling Task
timeFrame: Preoperative, 2 months after surgery, 6 months after surgery
measure: Tampa Scale of Kinesiophobia
timeFrame: Preoperative, 2 months after surgery, 6 months after surgery
Other outcomes:
measure: Biomarkers of Stress
timeFrame: Preoperative
measure: Biomarkers of Noradrenergic Functioning
timeFrame: Preoperative
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C Eisenach, MD
role: PRINCIPAL_INVESTIGATOR
References: