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Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

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ClinicalTrials.gov Identifier: NCT04437888
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Wayne E. Moschetti, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Arthroplasty Complications Drug: Ketamine Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a randomized, prospective double-blind, placebo controlled trial to evaluate the efficacy of intra-operative ketamine administration in patients undergoing elective total hip or knee arthroplasty, who have high pain catastrophizing scores.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The investigator, participant, research staff and medical provider will all be masked. The pharmacy will maintain the randomization and will provide the code at the conclusion of the study prior to data analysis.
Primary Purpose: Treatment
Official Title: Randomized Blinded, Placebo Controlled Trial Of Intrapoperative Ketamine For Patients Undergoing Total Joint
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Racemic Ketamine
ketamine 0.5mg/kg bolus on induction of anesthesia and 10mcg/kg/min infusion initiated prior to incision and terminated at the completion of wound closure. Maximum ketamine dose will not exceed 500mg
Drug: Ketamine
Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers

Placebo Comparator: Saline
saline in the same volume as the study drug, administered in the exact same format.
Drug: Ketamine
Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437888


Contacts
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Contact: Amy E. Hall, MS 603-653-3306 amy.e.hall@hitchcock.org
Contact: Peter A DePalo, Sr., BS 603-653-0494 Peter.A.DePalo.Sr@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Amy Hall, MS    603-653-3306 ext 6036533306    amy.e.hall@hitchcock.org   
Principal Investigator: Wayne Moschetti, MD, MS         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Wayne E Moschetti, MD, MS Dartmouth-Hitchcock Medical Center
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Responsible Party: Wayne E. Moschetti, Section Chief, Division of Adult Reconstructive Surgery, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04437888    
Other Study ID Numbers: D20116
STUDY02000376 ( Other Identifier: Dartmouth-Hitchcock )
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wayne E. Moschetti, Dartmouth-Hitchcock Medical Center:
Ketamine
Total Hip Replacement
Total Knee Replacement
Pain Catastrophizing
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action