Prevention of Post Mastectomy With Intraoperative Ketamine

NCT03090776 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 2016P002521K23GM110540
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Post-Mastectomy Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• postmastectomy pain

  assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment

  preoperative-2 years post

Study Arms (2)

unenriched

OTHER

all eligible women for partial or total mastectomy intervention will be ketamine or placebo saline

Drug: Ketamine; Other: Placebo saline

enriched for PPMP risk

OTHER

women at high risk for persistent pain after partial or total mastectomy intervention will be ketamine or placebo saline

Drug: Ketamine; Other: Placebo saline

Interventions

Ketamine DRUG

low dose bolus and infusion ketamine, administered under general anesthesia

Also known as: Ketalar

enriched for PPMP risk; unenriched

Placebo saline OTHER

bolus and infusion saline, administered under general anesthesia

enriched for PPMP risk; unenriched

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: women undergoing breast surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, 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

• Kristin L Schreiber, MD/PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational Drug service will prepare ketamine vs placebo infusion for administration during surgery
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, clinical researcher

Model Details: arm 1:unenriched for risk of PPMP, ketamine vs placebo arm 2: enriched for risk of PPMP, ketamine vs placebo

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: July 1, 2017
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 20, 2026

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)