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

• Sponsor: Carilion Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04439396
• Collaborator: (none)
• Enrollment: 183
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 42.3
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reduction; Breast Reconstruction	Drug: Ketorolac Tromethamine; Other: Saline	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomizedrandomized
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: double blind randomized trial
• Primary Purpose: Treatment
• Official Title: Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use
• Actual Study Start Date: Jun 22, 2020
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction of post-operative pain: Likert scale [2 week post operation]

   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.

Secondary Outcome Measures

1. Reduction of narcotic use [2 weeks post operation]

   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. Complication assessment [2 weeks to 90 days post operation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James T. Thompson	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

• Carilion Clinic

Investigators

• Principal Investigator: James Thompson, Carilion Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James T Thompson, Plastic and Reconstructive Surgeon, Carilion Clinic
• ClinicalTrials.gov Identifier: NCT04439396
• Other Study ID Numbers: 19-387
• First Posted: Jun 19, 2020
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Ketorolac; Ketorolac Tromethamine

Study Results

No Results Posted as of May 6, 2021