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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439396
• Other study ID #: 19-387
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Reconstruction
• Breast Reduction

Intervention

Drug:
• Ketorolac Tromethamine
nonsteroidal anti-inflammatory drug

Other:
• Saline
saline fluid injection

Locations

Country	Name	City	State
United States	James T. Thompson	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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