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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 : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Wayne E. Moschetti, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE June 16, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date November 22, 2021
Actual Study Start Date  ICMJE September 14, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2020)
  • 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
  • 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 function
  • 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.
  • Pain Catastrophizing Scale (PCS) [ Time Frame: post-operation at 6 weeks, 12 weeks, and 6 months ]
    13 question
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty
Official Title  ICMJE Randomized Blinded, Placebo Controlled Trial Of Intrapoperative Ketamine For Patients Undergoing Total Joint
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Pain, Postoperative
  • Arthroplasty Complications
Intervention  ICMJE Drug: Ketamine
Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ketamine
  • Placebo Comparator: Saline
    saline in the same volume as the study drug, administered in the exact same format.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04437888
Other Study ID Numbers  ICMJE D20116
STUDY02000376 ( Other Identifier: Dartmouth-Hitchcock )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wayne E. Moschetti, Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wayne E Moschetti, MD, MS Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP