Clinical trial NCT04439396: Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use
Official title: Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Reduction
Breast Reconstruction
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change of post-operative pain: Likert scale
timeFrame: 2 week post operation
Secondary outcomes:
measure: Change of narcotic use
timeFrame: 2 weeks post operation
measure: Complication assessment
timeFrame: 2 weeks to 90 days post operation
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: James T. Thompson
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: James Thompson
role: PRINCIPAL_INVESTIGATOR
References: