Phase 4
N=31
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04831736 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score — 16.7; 18.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score |
11.5; 15 | — |
| PRIMARY Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score |
11.5; 15 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score |
11.5; 15 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score |
11.5; 15 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score |
33.9; 32.9 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score |
33.9; 32.9 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score |
33.9; 32.9 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score |
33.9; 32.9 | — |
| SECONDARY Total Dosage of Opioid Use |
0.833; 7 | — |
| SECONDARY Total Dosage of Opioid Use |
0.833; 7 | — |
| SECONDARY Total Dosage of Opioid Use |
0.833; 7 | — |
| SECONDARY Total Dosage of Opioid Use |
0.833; 7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score |
49.1; 50.4 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score |
49.1; 50.4 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score |
49.1; 50.4 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score |
49.1; 50.4 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score |
51.7; 50.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score |
51.7; 50.7 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-2) Score |
2.13; 1.13 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-2) Score |
2.13; 1.13 | — |
| SECONDARY Breast Cancer Pain Questionnaire (BCPQ) - Pain Score |
3.53; 4.6 | — |
| SECONDARY Quality of Recovery (QoR-15) Survey Score |
81.6; 80.4 | — |
| SECONDARY Quality of Recovery (QoR-15) Survey Score |
81.6; 80.4 | — |
| SECONDARY Number of Participants Who Experience Side Effects |
8; 5 | — |
| SECONDARY Number of Participants Who Experience Side Effects |
8; 5 | — |
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
- Adult women, aged 18 to 80 years old, who will undergo mastectomy.
- Willing to comply with all study procedures and be available for the duration of the study.
- Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
- No distant metastases.
- Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Subject is medically stable.
Exclusion Criteria
- 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.
- Past ketamine or phencyclidine misuse or abuse.
- Schizophrenia or history of psychosis.
- Known sensitivity or allergy to ketamine.
- Liver or renal insufficiency.
- 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
- Pregnancy or nursing women
- BMI>35.
- Currently participating in another pain interventional trial.
- Unwillingness to give informed consent.
- Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Data sourced from ClinicalTrials.gov (NCT04831736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.