Clinical trial NCT04831736: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Mastectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
timeFrame: 24 Hours Post-Op (Day 2)
measure: Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
timeFrame: 48 Hours Post-Op (Day 3)
Secondary outcomes:
measure: Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
timeFrame: Baseline (Day 0)
measure: Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
timeFrame: Baseline (Day 0)
measure: Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
timeFrame: Day 1 Post-Op (Day 2)
measure: Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
timeFrame: Day 2 Post-Op (Day 3)
measure: Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Total Dosage of Opioid Use
timeFrame: Day of Surgery (Day 1)
measure: Total Dosage of Opioid Use
timeFrame: Day 1 Post-Op (Day 2)
measure: Total Dosage of Opioid Use
timeFrame: Day 2 Post-Op (Day 3)
measure: Total Dosage of Opioid Use
timeFrame: Day 7 Post-Op (Day 8)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
timeFrame: Baseline (Day 0)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
timeFrame: Day 1 Post-Op (Day 2)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
timeFrame: Day 2 Post-Op (Day 3)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
timeFrame: Baseline (Day 0)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Generalized Anxiety Disorder (GAD-2) Score
timeFrame: Baseline (Day 0)
measure: Generalized Anxiety Disorder (GAD-2) Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Breast Cancer Pain Questionnaire (BCPQ) - Pain Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Quality of Recovery (QoR-15) Survey Score
timeFrame: Day 2 Post-Op (Day 3)
measure: Quality of Recovery (QoR-15) Survey Score
timeFrame: Day 7 Post-Op (Day 8)
measure: Number of Participants Who Experience Side Effects
timeFrame: Day of Surgery (Day 1)
measure: Number of Participants Who Experience Side Effects
timeFrame: Day 1 Post-Op (Day 2)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lisa Doan, MD
role: PRINCIPAL_INVESTIGATOR
References: