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NCT Number: NCT04437888

Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

Prospective randomized double blinded, placebo controlled study that will evaluate the effect of intra-operative ketamine administration on post-operative analgesic requirements and self-reported pain in patients undergoing total hip and total knee arthroplasty who demonstrate high levels of pain catastrophizing.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States

About this study

Pain management can be one of the most challenging aspects of care for total joint arthroplasty patients. Poor post-operative pain control can lead to poor patient satisfaction and functional outcomes. Moreover, prolonged post-operative opioid utilization for post-operative pain is associated with substantial adverse sequelae. Identifying patients at high risk for poor post-operative pain control, and implementing strategies to improve pain management in this population is of utmost importance. One patient feature that has been shown to reliably predict poor post-operative pain management is pain catastrophizing. Currently available self-reported metrics such as the pain catastrophizing scale allow for pre-operative identification of patients who exhibit high levels of pain catastrophizing. Furthermore, there currently exist strategies which may effectively improve post-operative pain management in this population. One such strategy is "pre-emptive" analgesia utilizing ketamine administered at the time of surgery. Ketamine is commonly utilized in the treatment of both acute and chronic pain, and is believed to reduce pain intensity through a complex mechanism involving opioid receptors and excitatory neurotransmitters. It has been utilized in a variety of surgical procedures and has consistently been shown to reduce acute post-operative pain and analgesic consumption as long as 6 months after surgery, without a significant incidence of medication related side effects. To date, no study has evaluated the use of ketamine for total joint arthroplasty patients who demonstrate high levels of pain catastrophizing. We aim to study the effect of intra-operative ketamine administration on post-operative analgesic requirements and self-reported pain in patients undergoing total hip and total knee arthroplasty who demonstrate high levels of pain catastrophizing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults, 18 years and older, undergoing primary total hip arthroplasty or total knee arthroplasty

Exclusion criteria

  • History of intolerance or allergy to ketamine, either documented or self-reported.
  • History of increased intra-ocular pressure, uncontrolled hypertension, increased intra-cranial pressure, psychosis.
  • Unable to provide consent.
  • Current incarceration.
  • Pregnant or breast feeding

Treatment and study plan

ketamine

Drug

Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers

Primary outcomes

  1. Total Morphine consumption during the first 48 hours post surgery

    Time frame: Daily for six weeks

    Morphine consumption will be measured in a pain diary for 6- weeks post-surgical procedure. Decreased is morphine consumption will indicate effectiveness of ketamine administration

Secondary outcomes

  1. Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)

    Time frame: Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

    six question questionnaire measuring joint specific pain and physical function, scored by summing the raw response (range 0-24) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.

  2. Knee Disability and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

    Time frame: Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

    Seven question questionnaire measuring joint specific pain and physical functionscored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS-10)

    Time frame: Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

    patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. The higher the score the healthier the subject is compared to the general population.

  4. Pain Catastrophizing Scale (PCS)

    Time frame: post-operation at 6 weeks, 12 weeks, and 6 months

    The PCS is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The higher the score, the more catastrophizing thoughts are present.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Randomized Blinded, Placebo Controlled Trial of Intrapoperative Ketamine for Patients Undergoing Total Joint

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2020
Registry last updated
Sep 27, 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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