Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

• ClinicalTrials.gov Identifier: NCT04831736
• Recruitment Status: Recruiting
• First Posted: April 5, 2021
• Last Update Posted: March 4, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: April 1, 2021
• First Posted Date: April 5, 2021
• Last Update Posted Date: March 4, 2022
• Actual Study Start Date: April 26, 2021
• Estimated Primary Completion Date: March 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2021)

• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: 24 hours post-op ]
  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.
• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: 48 hours post-op ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 1, 2021)

• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: Baseline, Day 0 ]
  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.
• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: Day 1 post-op ]
  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.
• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: Day 2 post-op ]
  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.
• Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score [ Time Frame: Day 7 post-op ]
  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.
• Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score [ Time Frame: Baseline, Day 0 ]
  BPI Pain Interference Subscale consists of 7 questions (asking 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.
• Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score [ Time Frame: Day 1 post-op ]
  BPI Pain Interference Subscale consists of 7 questions (asking 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.
• Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score [ Time Frame: Day 2 post-op ]
  BPI Pain Interference Subscale consists of 7 questions (asking 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.
• Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score [ Time Frame: Day 7 post-op ]
  BPI Pain Interference Subscale consists of 7 questions (asking 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.
• Total dosage of opioid use [ Time Frame: Baseline, Day 0 ]
  Use and dosage will be assess through medical records and subject reports.
• Total dosage of opioid use [ Time Frame: Day 1 post-op ]
  Use and dosage will be assess through medical records and subject reports.
• Total dosage of opioid use [ Time Frame: Day 2 post-op ]
  Use and dosage will be assess through medical records and subject reports.
• Total dosage of opioid use [ Time Frame: Day 7 post-op ]
  Use and dosage will be assess through medical records and subject reports.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7b Daily Score [ Time Frame: Baseline, Day 0 ]
  The PROMIS Fatigue Short Form consists of 7 questions. Each is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7b Daily Score [ Time Frame: Day 1 post-op ]
  The PROMIS Fatigue Short Form consists of 7 questions. Each is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7b Daily Score [ Time Frame: Day 2 post-op ]
  The PROMIS Fatigue Short Form consists of 7 questions. Each is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7b Daily Score [ Time Frame: Day 7 post-op ]
  The PROMIS Fatigue Short Form consists of 7 questions. Each is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score [ Time Frame: Baseline, Day 0 ]
  The PROMIS Sleep Disturbance Short Form consists of 6 statements. Each is answered with a score of 1-5 (varies). The total range of score is 1-30; the lower the score, the better the quality of sleep.
• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score [ Time Frame: Day 7 post-op ]
  The PROMIS Sleep Disturbance Short Form consists of 6 statements. Each is answered with a score of 1-5 (varies). The total range of score is 1-30; the lower the score, the better the quality of sleep.
• Generalized Anxiety Disorder (GAD-2) Score [ Time Frame: Baseline, Day 0 ]
  GAD-2 consists of 2 statements/problems (assessing how often one has been bothered by the 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.
• Generalized Anxiety Disorder (GAD-2) Score [ Time Frame: Day 7 post-op ]
  GAD-2 consists of 2 statements/problems (assessing how often one has been bothered by the 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.
• Breast Cancer Pain Questionnaire (BCPQ) - Pain Score [ Time Frame: Day 7 post-op ]
  If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, dependent on the location, 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.
• Quality of Recovery (QoR-15) Survey Score [ Time Frame: Day 2 post-op ]
  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 (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 respond to each symptom on whether they have experienced any in the last 24 hours (10 to 0, where 10 is none of the time [excellent] and 10 is all of the time [none]). The total range of score for Part B is 0-50; the higher the score, the worse.
• Quality of Recovery (QoR-15) Survey Score [ Time Frame: Day 7 post-op ]
  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 (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 respond to each symptom on whether they have experienced any in the last 24 hours (10 to 0, where 10 is none of the time [excellent] and 10 is all of the time [none]). The total range of score for Part B is 0-50; the higher the score, the worse.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
• Official Title: Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Postoperative Pain

Intervention

• 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.
• Drug: Placebo
  Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.

Study Arms

• Experimental: Treatment
  Intervention: Drug: Ketamine
• Placebo Comparator: Control
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 1, 2021): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2022
• Estimated Primary Completion Date: March 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lisa Doan, MD; 212-201-1004; Lisa.Doan@nyulangone.org

Contact: Anna Li; 212-263-1538; anna.li@nyulangone.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04831736
• Other Study ID Numbers: 21-00072
• Has Data Monitoring Committee: No

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

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• 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: 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.

• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lisa Doan, MD; NYU Langone Health

• PRS Account: NYU Langone Health
• Verification Date: March 2022