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Prevention of Post Mastectomy With Intraoperative Ketamine

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ClinicalTrials.gov Identifier: NCT03090776
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Kristin Schreiber, Brigham and Women's Hospital

Brief Summary:

Aim 1: To determine the effectiveness of perioperatively administered ketamine to decrease acute and persistent postmastectomy pain (PPMP).

Hypothesis 1.1: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased postoperative pain and opioid utilization compared to those receiving saline control.

Hypothesis 1.2: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased persistent postoperative pain measured at one year after surgery.

Aim 2: To determine whether there is increased power to detect therapeutic effectiveness in an interventional preventive trial, by enrichment with patients at high risk of PPMP.

Hypothesis 2.1: Ketamine will have a greater analgesic and opioid sparing effect on pain scores in high-risk patients than non-high risk patients, compared to placebo.

Hypothesis 2.2: Ketamine will have a greater preventive effect on pain burden scores at one year after surgery in high-risk patients than non-high risk patients, compared to placebo.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Post-Mastectomy Chronic Pain Syndrome Drug: Ketamine Other: Placebo saline Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: arm 1:unenriched for risk of PPMP, ketamine vs placebo arm 2: enriched for risk of PPMP, ketamine vs placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigational Drug service will prepare ketamine vs placebo infusion for administration during surgery
Primary Purpose: Prevention
Official Title: Prevention of Post-Mastectomy Pain With Perioperative Ketamine Administration: A Randomized, Placebo-controlled Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
Drug Information available for: Ketamine

Arm Intervention/treatment
unenriched
all eligible women for partial or total mastectomy intervention will be ketamine or placebo saline
Drug: Ketamine
low dose bolus and infusion ketamine, administered under general anesthesia
Other Name: Ketalar

Other: Placebo saline
bolus and infusion saline, administered under general anesthesia

enriched for PPMP risk
women at high risk for persistent pain after partial or total mastectomy intervention will be ketamine or placebo saline
Drug: Ketamine
low dose bolus and infusion ketamine, administered under general anesthesia
Other Name: Ketalar

Other: Placebo saline
bolus and infusion saline, administered under general anesthesia




Primary Outcome Measures :
  1. postmastectomy pain [ Time Frame: preoperative-2 years post ]
    assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women undergoing breast surgery
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • female
  • aged 18-85 years
  • scheduled for total or partial mastectomy
  • willingness to undergo psychophysical and psychosocial testing
  • willingness to participate in long-term follow-up
  • willingness to be randomized to treatment with IV ketamine or saline during general anesthesia.

Exclusion criteria:

  • scheduled for biopsy only
  • pregnant
  • elevated ICP
  • schizophrenia or bipolar disorder
  • allergy to ketamine
  • Class III or higher heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090776


Contacts
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Contact: Kristin Schreiber, MD/PhD 612-205-0186 klschreiber@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kristin Schreiber, MD/PhD    612-205-0186    klschreiber@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)

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Responsible Party: Kristin Schreiber, Anesthesiologist, clinical researcher, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03090776     History of Changes
Other Study ID Numbers: 2016P002521
K23GM110540 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Chronic Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action