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Completed

NCT Number: NCT01680549

Pain Control With Total Knee Replacement

The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

25 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TTUHSC Orthopaedic Surgery MS 9436

Lubbock, Texas, 79430, United States

About this study

Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age > 25 years old
  • Primary osteoarthritis of the knee
  • Must be undergoing unilateral total knee arthroplasty
  • Anesthesia assesment score I, II, or III

Exclusion criteria

  • Severe joint malalignment (defined as varus/valgus angle > 20 deg)
  • Use of gabapentin pre-operatively
  • History of chronic pain (currently under treatment)
  • History of substance abuse
  • Impaired kidney function (defined as creatinine > 1.5)
  • Epilepsy (currently on medication for treatment)
  • Known allergy to Gabapentin
  • Known history of depression or suicidal thoughts and behaviors
  • Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.

Treatment and study plan

Gabapentin

Drug

Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.

Other names: Fanatrex, Gabarone, Gralise, Horizant, Neurontin

Primary outcomes

  1. Patient Pain Scores

    Time frame: 3 days

    Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.

    Scale range: 0-100 Higher Values = More Pain

Secondary outcomes

  1. Narcotics Consumption

    Time frame: 3 days

    Narcotics consumption was recorded on postoperative days 0, 1, and 2.

  2. Knee Range of Motion

    Time frame: 3 days

    Patient knee range of motion was assessed on postoperative days 0, 1 and 2.

  3. Patient Restfulness

    Time frame: 3 days

    Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.

Acronym: L12-078

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2012
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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