Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

Randomized Blinded, Placebo Controlled Trial Of Intrapoperative Ketamine For Patients Undergoing Total Joint

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04437888
• Other study ID #: D20116
• Secondary ID: STUDY02000376
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 14, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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