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Gabapentin for Pain

Phase 4
Waitlist Available
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 months after surgery, 6 months after surgery
Awards & highlights

Study Summary

This study is evaluating whether a drug may help improve recovery after knee surgery.

Eligible Conditions
  • Pain
  • Total Knee Arthroplasty
  • Total Hip Replacement

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 2 months after surgery, 6 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, 2 months after surgery, 6 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo-- Slope
Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept
Effect Pupil Diameter, Catastrophizing-optimism Construct, and Gabapentin on Model Fit of the Trajectory of Change in Worst Daily Pain After Surgery
Secondary outcome measures
Iowa Gambling Task
Tampa Scale of Kinesiophobia
Wisconsin Card Sort Task
Other outcome measures
Biomarkers of Noradrenergic Functioning
Biomarkers of Stress

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GabapentinActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,376 Total Patients Enrolled
22 Trials studying Pain
2,107 Patients Enrolled for Pain
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
246,762 Total Patients Enrolled
8 Trials studying Pain
505 Patients Enrolled for Pain
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
485 Total Patients Enrolled
1 Trials studying Pain
80 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Predicting, Understanding and Speeding Recovery After TKA
2016. "Predicting, Understanding and Speeding Recovery After TKA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02685735.
~40 spots leftby Apr 2025
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