Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty

NCT04437888 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: D20116STUDY02000376
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Arthroplasty Complications

Keywords

Ketamine; Total Hip Replacement; Total Knee Replacement; Pain Catastrophizing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)

  Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

• Knee Disability and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

  Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

• Patient-Reported Outcomes Measurement Information System (PROMIS-10)

  Pre-operation, post-operation at 6 weeks, 12 weeks, and 6 months

• Pain Catastrophizing Scale (PCS)

  post-operation at 6 weeks, 12 weeks, and 6 months

Study Arms (2)

Racemic Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Saline

PLACEBO COMPARATOR

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

Drug: Ketamine

Interventions

Ketamine DRUG

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

Racemic Ketamine; Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18 years and older, undergoing primary total hip arthroplasty or total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Wayne E Moschetti, MD, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Division of Adult Reconstructive Surgery

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: September 14, 2020
• Primary Completion: April 5, 2024
• Study Completion: June 1, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)