Breast Cancer Female Clinical Trial
— KANGAROOOfficial title:
Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn
Verified date | August 2017 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been
shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and
obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and
central nervous system depression post operatively, while still providing adequate pain
control for patients. Patients undergoing abdominally based microsurgical breast
reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be
safely discharged from hospital sooner than their counterparts receiving standard of care.
Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical
breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in
addition to standard of care, reduce the length of postoperative hospital stay compared with
an intravenous sham saline regimen?
Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm,
parallel group, superiority, randomized, and double blinded, controlled trial.
Population: The study population includes all females >18 years old post mastectomy
consenting to abdominally based microsurgical breast reconstruction.
Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours
postoperatively for 72 hours. The comparator will be a sham intravenous administration of
normal saline.
Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes
include visual analog scale for pain, breakthrough narcotic consumption, surgical drain
outputs, hematoma, and other complications.
Sample Size: Available data provided estimates for average length of hospital stay and
standard deviation. A minimally clinically significant difference of 1 day was decided on due
to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for
attrition and efficiency losses, a total of 50 patients (25 per group) will be required for
this study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients 18 years of age or older will be offered inclusion if they are scheduled to undergo unilateral or bilateral postmastectomy abdominally based free flap BR postmastectomy, either in a delayed fashion or at the time of initial mastectomy(ies). Exclusion Criteria: - Patients will be excluded if they meet any of the exclusion criteria: male; revision surgery; a planned pedicled flap reconstruction; any previous diagnosis of chronic renal disease, gastric ulcers, or bleeding disorder; acetaminophen, NSAID or specific ketorolac sensitivity or allergy; pregnancy; or opioid tolerance defined as preoperative opioid use greater than 50 mg. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Bonde C, Khorasani H, Eriksen K, Wolthers M, Kehlet H, Elberg J. Introducing the fast track surgery principles can reduce length of stay after autologous breast reconstruction using free flaps: A case control study. J Plast Surg Hand Surg. 2015;49(6):367-71. doi: 10.3109/2000656X.2015.1062387. Epub 2015 Jul 10. — View Citation
Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SO. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial. Plast Reconstr Surg. 2014 Nov;134(5):870-8. doi: 10.1097/PRS.0000000000000613. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospital stay postoperatively | recorded in days beginning post operative day number one | measured when the patient leaves the hospital, averages between 3-9 days | |
Secondary | Visual analog scale for pain | Standard for for visual analog scale | every 6 hours for 72 hours | |
Secondary | Narcotic consumption | Total narcotic consumption over first 72 hours converted to morphine equivalence | 72 hours | |
Secondary | Surgical drain output | Total surgical drain output over first 72 hours | 72 hours | |
Secondary | Hematoma | Any hematoma requiring management in the operating room | measured when the patient leaves the hospital, averages between 3-9 days | |
Secondary | Adverse events | Any infection requiring antibiotics, or flap complications requiring management in the operating room | measured when the patient leaves the hospital, averages between 3-9 days |
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