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Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

NCT03007381 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-08-16

No results posted yet for this study

Summary

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

  • Breast Cancer Female

Interventions

DRUG

Ketorolac Tromethamine

Intravenous analgesic

DRUG

Normal Saline

Sham comparator

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Joseph P Corkum, MD · NSHA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2019-01-31
Completion
2019-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007381 on ClinicalTrials.gov