Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.

The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult women, aged 18 to 80 years old, who will undergo mastectomy.
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
4. No distant metastases.
5. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
6. Subject is medically stable.

Exclusion Criteria:

1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
2. Past ketamine or phencyclidine misuse or abuse.
3. Schizophrenia or history of psychosis.
4. Known sensitivity or allergy to ketamine.
5. Liver or renal insufficiency.
6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
7. Pregnancy or nursing women
8. BMI>35.
9. Currently participating in another pain interventional trial.
10. Unwillingness to give informed consent.
11. Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Placebo; Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
Experimental: Treatment	Drug: Ketamine; Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score	BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.	24 Hours Post-Op (Day 2)
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score	BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.	48 Hours Post-Op (Day 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Dosage of Opioid Use	Use and dosage will be assessed through medical records and subject reports.	Day of Surgery (Day 1)
Total Dosage of Opioid Use	Use and dosage will be assessed through medical records and subject reports.	Day 1 Post-Op (Day 2)
Total Dosage of Opioid Use	Use and dosage will be assess through medical records and subject reports.	Day 2 Post-Op (Day 3)
Total Dosage of Opioid Use	Use and dosage will be assess through medical records and subject reports.	Day 7 Post-Op (Day 8)
Generalized Anxiety Disorder (GAD-2) Score	GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety.	Baseline (Day 0)
Generalized Anxiety Disorder (GAD-2) Score	GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety.	Day 7 Post-Op (Day 8)
Quality of Recovery (QoR-15) Survey Score	Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling.	Day 7 Post-Op (Day 8)
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score	BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.	Baseline (Day 0)
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score	BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.	Day 7 Post-Op (Day 8)
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score	BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.	Baseline (Day 0)
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score	BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.	Day 1 Post-Op (Day 2)
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score	BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.	Day 2 Post-Op (Day 3)
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score	BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.	Day 7 Post-Op (Day 8)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score	The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.	Baseline (Day 0)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score	The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.	Day 1 Post-Op (Day 2)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score	The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.	Day 2 Post-Op (Day 3)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score	The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.	Day 7 Post-Op (Day 8)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score	The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance.	Baseline (Day 0)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score	The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance.	Day 7 Post-Op (Day 8)
Breast Cancer Pain Questionnaire (BCPQ) - Pain Score	If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. The total score is the sum of responses from each location.	Day 7 Post-Op (Day 8)
Quality of Recovery (QoR-15) Survey Score	Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Total scores range from 0-150; the higher the score, the better the participant has been feeling.	Day 2 Post-Op (Day 3)
Number of Participants Who Experience Side Effects	Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects of ketamine. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events.	Day of Surgery (Day 1)
Number of Participants Who Experience Side Effects	Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events.	Day 1 Post-Op (Day 2)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lisa Doan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Mastectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 21-00072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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