Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.

Detailed Description
-----------------
The investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures. Patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will be the control and receive a placebo of saline. Patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit. The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. If patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. Additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. The patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.

Official Title
-----------------
Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use

Conditions
-----------------
Breast Reduction, Breast Reconstruction

Intervention / Treatment
-----------------
* Drug: Ketorolac Tromethamine
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient consents to study Adult females needing breast reconstruction or breast reduction (day surgeries) Exclusion Criteria: Patients with known kidney disease Patient does not consent patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood thinners use, bariatric surgery and any other contraindications of Toradol use patients currently taking aspirin pregnant women (not standard to operate on this population anyway)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Saline injection administered during surgical procedure | Other: Saline<br>* saline fluid injection<br>|
| Experimental: Low Dose (15mg) Toradol<br>15mg ketorolac (toradol) administered during surgery | Drug: Ketorolac Tromethamine<br>* nonsteroidal anti-inflammatory drug<br>* Other names: Toradol;|
| Experimental: High Dose (30mg) Toradol<br>30mg ketorolac (toradol) administered during surgery | Drug: Ketorolac Tromethamine<br>* nonsteroidal anti-inflammatory drug<br>* Other names: Toradol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of post-operative pain: Likert scale | This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit. | 2 week post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of narcotic use | This will be assessed by calculating the Medial Morphine Equivalent (MME) in the post-operative period. This will include narcotics given while in the hospital and narcotics prescribed and used at home in the patient diary. Perioperative narcotic use will also be recorded. | 2 weeks post operation | 
| Complication assessment | Assess complications including, but not limited to, hematomas, GI issues (nausea, diarrhea, indigestion, heartburn), and headaches. This will be assessed by tracking any readmissions for hematoma evacuation or other complications reported at their post-op follow up visit. | 2 weeks to 90 days post operation |