Predicting, Understanding and Speeding Recovery After TKA

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Terminated
Phase 4

Conditions

Total Hip Replacement
Pain
Total Knee Replacement

Treatments

Drug: Placebo
Drug: Gabapentin

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02685735
5P01GM113852 (U.S. NIH Grant/Contract)
IRB00032506

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

350 participants in 2 patient groups, including a placebo group

Gabapentin
Active Comparator group
Description:
Subjects will be randomized, stratifying for norepinephrine serotonin reuptake inhibitor (NSRI) use, to equal number to receive gabapentin or placebo pills. Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.
Treatment:
Drug: Gabapentin
Placebo
Placebo Comparator group
Description:
Subjects will be randomized, stratifying for norepinephrine serotonin reuptake inhibitor (NSRI) use, to equal number to receive gabapentin or placebo pills. Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards.
Treatment:
Drug: Placebo

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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