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Completed

NCT Number: NCT04439396

Toradol (Ketorolac) in Breast Surgery to Reduce Pain & 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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

James T. Thompson

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketorolac Tromethamine

Drug

nonsteroidal anti-inflammatory drug

Other names: Toradol

Saline

Other

saline fluid injection

Primary outcomes

  1. Change of post-operative pain: Likert scale

    Time frame: 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 outcomes

  1. Change of narcotic use

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 19, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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