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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction; Breast Reduction
• Intervention / Treatment: Other: Saline; Drug: Ketorolac Tromethamine

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • James T. Thompson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Saline injection administered during surgical procedure	Other: Saline; saline fluid injection
EXPERIMENTAL: Low Dose (15mg) Toradol; 15mg ketorolac (toradol) administered during surgery	Drug: Ketorolac Tromethamine; nonsteroidal anti-inflammatory drug; Other Names: Toradol
EXPERIMENTAL: High Dose (30mg) Toradol; 30mg ketorolac (toradol) administered during surgery	Drug: Ketorolac Tromethamine; nonsteroidal anti-inflammatory drug; 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

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: James Thompson, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2020
• Primary Completion (ACTUAL): January 30, 2023
• Study Completion (ACTUAL): January 30, 2023

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: 19-387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No