Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Saline

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

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No