Pain, Postoperative Clinical Trial
Official title:
Randomized Blinded, Placebo Controlled Trial Of Intrapoperative Ketamine For Patients Undergoing Total Joint
Verified date | September 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Morphine consumption during the first 48 hours post surgery | 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 | Daily for six weeks | |
Secondary | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) | 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. | Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months | |
Secondary | Knee Disability and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | 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. | Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months | |
Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS-10) | 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. | Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months | |
Secondary | Pain Catastrophizing Scale (PCS) | 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. | post-operation at 6 weeks, 12 weeks, and 6 months |
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