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

Carilion Clinic

Status and phase: Completed; Phase 1

Conditions: Breast Reconstruction; Breast Reduction

Treatments: Drug: Ketorolac Tromethamine; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04439396

19-387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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183 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Saline injection administered during surgical procedure

Treatment:

Other: Saline

Low Dose (15mg) Toradol

Experimental group

Description:

15mg ketorolac (toradol) administered during surgery

Treatment:

Drug: Ketorolac Tromethamine

High Dose (30mg) Toradol

Experimental group

Description:

30mg ketorolac (toradol) administered during surgery

Treatment:

Drug: Ketorolac Tromethamine