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

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ClinicalTrials.gov Identifier: NCT05037123

Recruitment Status : Recruiting

First Posted : September 8, 2021

Last Update Posted : October 13, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

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

October 13, 2022

Actual Study Start Date ^ICMJE

January 4, 2022

Estimated Primary Completion Date

October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

Original Primary Outcome Measures ^ICMJE

BPI pain severity subscale score [ Time Frame: 3 months ]

Change History

Current Secondary Outcome Measures ^ICMJE

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. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
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. The BCPQ queries patients about pain severity (scores 1-10) and frequency (scores 5 [constantly], 4 [daily], 3 [occasionally], 2 [weekly], 1 [monthly], and 0 [never]) in four surgically related body areas (breast, axilla, chest wall, arm).
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. The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

Original Secondary Outcome Measures ^ICMJE

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.

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

The 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 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) 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: Supportive Care

Condition ^ICMJE

Chronic Postsurgical Pain

Intervention ^ICMJE

Drug: Continuous ketamine infusion
Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 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 group
Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 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 Ketamine + Saline group
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 group
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

Recruiting

Estimated Enrollment ^ICMJE

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

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

United States

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.