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Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

Primary Purpose

Pain, Postoperative, Arthroplasty Complications

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Ketamine, Total Hip Replacement, Total Knee Replacement, Pain Catastrophizing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Racemic Ketamine

Saline

Arm Description

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

saline in the same volume as the study drug, administered in the exact same format.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 16, 2020
Last Updated
September 19, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04437888
Brief Title
Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty
Official Title
Randomized Blinded, Placebo Controlled Trial Of Intrapoperative Ketamine For Patients Undergoing Total Joint
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Arthroplasty Complications
Keywords
Ketamine, Total Hip Replacement, Total Knee Replacement, Pain Catastrophizing

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Racemic Ketamine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
saline in the same volume as the study drug, administered in the exact same format.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers
Primary Outcome Measure Information:
Title
Total Morphine consumption during the first 48 hours post surgery
Description
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
Time Frame
Daily for six weeks
Secondary Outcome Measure Information:
Title
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
Description
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.
Time Frame
Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months
Title
Knee Disability and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
Description
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.
Time Frame
Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Description
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.
Time Frame
Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
post-operation at 6 weeks, 12 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne E Moschetti, MD, MS
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

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