All team members will be extensively trained on the proceedings of this trial
Patients will be recruited at their initial consultation, or subsequent
pre-operative visit.
All patients that are approached will be recorded into an excel sheet. If they
decline the study- this will be listed along with any provided reasoning for
declining.
Once consent is obtained, the patient will be randomized into either the study group
(receiving intraoperative subpectoral bupivacaine) or the control group (will not
receive subpectoral bupivacaine.) Block randomization will be performed using
randomizer.org. For every forty patients, twenty will be randomized into the control
group, and twenty into the bupivacaine group. Patients will be blinded to the which
group they are placed in. The PI and study staff are not blinded.
Per standard protocol, patients will undergo urine pregnancy testing in the
pre-operative area. If results are positive, patients will be informed of the
results in a private area. Surgery will be postponed and patients will be then
excluded from the study.
Patients will undergo their procedure with their assigned intervention.
Intra-operative anesthetic and pain control regimens will otherwise be standardized
with the anesthesia team to remove other confounding factors/variables.
Administration of the saline/bupivacaine will be just below the fascia of the
pectroalis major. This will occur following resection of the specimen and
achievement of hemostasis, prior to closure of the wounds. Injections will be in a
fan-like pattern, beginning at the inferolateral border of the pectoral is muscle,
extending superomedially with injection, spanning the anterior surface of the
pectroalis major. This will be performed under direct visualization; no imaging
assistance is necessary. Each patient will receive 5 injections, 3mL per injection
bilaterally. A total of 30mL of saline or bupivacaine will be injected.
PACU nurses will record pain scores upon arrival into the PACU, as well as upon
discharge home from the hospital. All patients will receive the same amount of
prescribed narcotic. They will be sent home with a log. Patients will record a daily
pain score, and the number of doses of ibuprofen, acetaminophen and oxycodone.
As an internal quality control measure, research staff will call patients within 72
hours from surgery to ensure they are completing the pain score and medication log
daily.
The clinician (MD, PA, or nurse) will go through the survey questions with patients
at their 1 and 4 week post-operative visits. These questions are typical questions
asked at follow-up and will not add significant time to the clinic visit. All
clinical staff asking these surveys is familiar with the information. (see
appendices)
Data will be collected at the 1 and 4 week post-operative visit in the plastic
surgery clinic Further data (PACU length of stay, PACU pain scores) will be
determined by performing chart review.
To minimize error and maximize quality, only a few clinicians (3-4 max) will be
those obtaining the survey results in clinic. All questions will be asked by reading
verbatim from the survey to avoid bias when questioning. Scores will be entered into
an excel file each day at the end of clinic.
The spreadsheet will be password protected to ensure patient privacy. Only the
surgeon, PA and RN will have access to this.
Interim analyses will be performed after 60 patients have undergone treatment in
order to assess if the study is meeting the intended objectives.
