Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03535116 |
| Other study ID # |
33 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Dr. Chandran Medical Prof Corp |
| Contact |
Geethan Chandran, MD |
| Phone |
(306)380-3910 |
| Email |
drgeethanchandran[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for
postoperative pain control increases hematoma and bleeding in breast reduction surgery.
However, there is no literature that supports this teaching. Ketorolac is used routinely in
free flap reconstruction including breast reconstruction as well as many other surgeries
including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been
shown to give good postoperative pain control. The object of this study is to look at whether
ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no
increased risk of hematoma, then ketorolac can be used safely for postoperative pain control
with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma
rates in a breast reduction are 1-2%.
Description:
STUDY PROTOCOL
The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A
Double Blind Randomized Control Trial
Purpose: The purpose of this study to investigate hematoma rates of a single dose of
ketorolac given intra-operatively in breast reduction surgery.
Hypothesis: There is no statistically significant difference between the ketorolac and
placebo in hematoma rates after intra-operative single use in breast reduction surgery.
PROTOCOL
A Power analysis and sample size estimation was carried out with an alpha=0.05 and a
beta=0.80. This gave the study a power of 0.94 and sample size estimation of 260 patients per
group.
A consent form will be developed and the University of Saskatchewan ethics approval will be
obtained. The study will be registered as a trial through ClinicalTrials.gov.
The plastic surgeons in the study will start recruiting patients during their initial
consultation for breast reduction. The consultation will determine if the patient is a
candidate for a breast reduction clinically. The candidacy for a breast reduction is
determined strictly on a clinical basis and only then the patient will be considered to
participate in the study. If the patient meets inclusion criteria, the patient will be asked
to participate in the study. The process of the study as it pertains to the patient and the
risks/benefits of the study and the study medication will be discussed with the patient by
the surgeon.
If the patient agrees to participate in the study, they will be asked to sign the consent
form on the day of surgery. They will have a patient number(1-260) assigned to them. A
computer generated randomization process will determine if the patient will get ketorolac or
saline(placebo). A small piece of paper with either of the words "ketorolac" or "saline" will
be placed in an envelope with the corresponding patient number and sealed. This randomization
and envelope will be administered by the clinic nurse and a computer spreadsheet of the
patient number and medication to administered will be kept by the clinic nurse. The surgeon
or patient will not have knowledge of this.
The breast reduction surgery will be performed in the usual manner as clinically dictated.
The anesthetist will be given the sealed envelope at the beginning of the case. Towards the
end of the operation, the anesthetist will open the envelope and administer the medication as
indicated in the content of the envelope, reseal the envelope and record what was given on
their anesthetic record. The surgeon will not have any knowledge of what medication was
administered.
After the breast reduction is finished, the patient will be transferred to the recovery room.
The surgeon will examine the patient in the recovery room or day surgery before the patient
is discharged to determine if there is a hematoma. If there is a hematoma, the surgeon will
inform the clinic nurse of such and the treatment of the hematoma(eg. Re-operation,
observation etc). Before the patient is discharged, the day surgery nurse will ask the
patient to indicate on the visual analog scale about their pain level(scale of 1-10). Then
the patient will be discharged home if appropriate. The patient will have instructions on the
signs of hematoma to watch out for in the form of written instructions.
Two weeks postoperatively and 6 weeks postoperatively, the patient will be seen for a
followup by the clinic nurse as an independent assessor for a hematoma. The presence or
absence of a hematoma will be recorded. If there is a hematoma, the surgeon will be notified
to assess the patient. The treatment of the hematoma will be communicated to the clinic nurse
by the surgeon.
After the 6 week followup, the study for that patient will be finished. If the patient wishes
to know what medication that they received intra-operatively, the clinic nurse can inform
them at that point.
All data will be stored in a password protected computer at Dr. Chandran's office at 210-206
Wellman Crescent, Saskatoon, Saskatchewan, Canada. At no point will any of the identifiable
data in this study's database be transferred off the premises.
After the collection of data for all patients, the data will be analyzed by the statistician
for the Department of Surgery of the University of Saskatchewan or their equivalent. The data
will be de-identified of patient names before sending to the statistician. A master list with
the patient names and the corresponding patient number will only be kept at Dr. Chandran's
office(above). The results will be discussed by the research team and
publication/presentation shall be determined.
