Clinical trial · Interventional

Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

NCT03007381CI-TRIAL-00029100KANGAROOwithdrawnPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): No funding.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer Female	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Ketorolac Tromethamine	Drug	—	UNRESOLVED
Normal Saline	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Ketorolac tromethamine
description
Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the ketorolac intervention group, then the participant will receive 30 mg of intravenous (IV) ketorolac tromethamine. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.
interventionNames
1. Drug: Ketorolac Tromethamine
type
SHAM_COMPARATOR
label
Normal Saline
description
Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the control group the patient will be given a sham IV medication. The sham medication will be normal saline at the same volume as ketorolac, which corresponds to 3 ccs. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (2)

BACKGROUNDBonde 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. PMID 26161838
BACKGROUNDZhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SOP. 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):870-878. doi: 10.1097/PRS.0000000000000613. PMID 25347623