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Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain (KALPAS)

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ClinicalTrials.gov Identifier: NCT05037123
Recruitment Status : Not yet recruiting
First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 31, 2021
First Posted Date  ICMJE September 8, 2021
Last Update Posted Date September 8, 2021
Estimated Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
BPI pain severity subscale score [ Time Frame: 3 months ]
The Brief Pain Inventory short form (BPI) pain severity subscale assesses pain at its worst, least, average, and current in the past 24 hours. The score ranges from 0 to 10 for each item. The average of the four items will be used.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • BPI pain severity and pain interference subscales score [ Time Frame: Baseline, 1 and 7 days and 1, 3*, 6, and 12 months after surgery ]
    BPI assesses pain severity and interference. The interference subscale measures how much pain has interfered with general activities such as walking and working. Additionally, it inquires about interference in mood, enjoyment of life, relationships, and sleep.
  • Incidence of PMS: BPI average pain score [ Time Frame: Baseline, 3, 6, and 12 months after surgery ]
    The BPI pain severity subscale assesses pain at its worst, least, average, and current in the past 24 hours. We will use participant's average pain item to assess incidence of PMPS. A score greater than 3 (0-10 scale) will be considered clinically meaningful chronic pain.
  • Pain in the surgical site (chest wall, axilla, and/or arm): BCPQ Score [ Time Frame: 7 days and 1, 3, 6, and 12 months after surgery ]
    The Breast Cancer Pain Questionnaire (BCPQ) assesses pain location, frequency, and severity as well as sensory disturbance after breast surgery.
  • Anxiety and depressed mood: Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, 7 days and 1, 3, 6, and 12 months after surgery ]
    Anxiety and depressive symptoms are prevalent in patients undergoing surgery for breast cancer and are risk factors for PMPS.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Official Title  ICMJE Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Brief Summary Our study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.3 mg/kg/hr infusion throughout surgery and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Participants, study members, and treating clinicians will be blinded to intervention.
Primary Purpose: Treatment
Condition  ICMJE Chronic Postsurgical Pain
Intervention  ICMJE
  • Drug: Continuous ketamine infusion
    Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.3 mg/kg/hr until 2 hours after surgery) plus saline IV dose in post-anesthesia care unit
  • Drug: Ketamine + Saline
    Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery
  • Other: Placebo
    Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.3 mg/kg/hr until 2 hours after surgery) plus saline IV dose in post-anesthesia care unit
    Intervention: Drug: Continuous ketamine infusion
  • Active Comparator: Arm 2
    Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery
    Intervention: Drug: Ketamine + Saline
  • Placebo Comparator: Arm 3
    Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2021)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Woman 18 years of age or older
  • Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy, prophylacticmastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction.
  • No distant metastases

Exclusion Criteria:

  • History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness, etc.
  • Past ketamine or phencyclidine misuse or abuse
  • Schizophrenia or history of psychosis
  • History of post-traumatic stress disorder
  • Known sensitivity or allergy to ketamine
  • Liver or renal insufficiency
  • History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine
  • Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use
  • Currently Pregnant
  • Body mass index (BMI) greater than 35
  • Non-English or non-Spanish speaker
  • Currently participating in another pain interventional trial
  • Unwilling to comply with all study procedures and be available for the duration of the study
  • Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6
  • Patient has started or undergone hormone therapy for gender transition into male.
  • Patient scheduled for any bilateral (or greater) flap reconstruction
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jing Wang, MD, PhD 212-263-5072 Jing.Wang2@nyulangone.org
Contact: Randy Cuevas 2122631538 Randy.Cuevas@nyulangone.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05037123
Other Study ID Numbers  ICMJE 21-00715
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: Requests should be directed to Jing.Wang2@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jing Wang, MD, PhD NYU Langone
PRS Account NYU Langone Health
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP