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Current Practice Arm for Pain
N/A
Waitlist Available
Led By Jeffrey Kenkel
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0- day 7
Awards & highlights
Study Summary
This trial is testing whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0- day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0- day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative Pain Questionnaire
Secondary outcome measures
Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey
Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome
Post operative Quality of Life Questionnaire
Trial Design
2Treatment groups
Active Control
Group I: Current Practice ArmActive Control1 Intervention
The current practice arm will include: post-operatively, hydrocodone-acetaminophen 5/325mg tabs and ibuprofen 800mg, as needed for pain. Additionally, acetaminophen may be used in conjunction with the above regiment. Ibuprofen and acetaminophen can be taken as needed or alternating every 6 hours, scheduled.
Group II: Enhanced Recovery After Surgery (ERAS) ArmActive Control1 Intervention
ERAS Arm will undergo multimodal regiment:
Before Surgery- gabepentin 300mg and celecoxib 400mg once the day before surgery and again 3 hours prior to surgery.
During surgery- subjects will receive ketorolac 30mg IV ketorolac once (15mg for patients age 64 years and above).
Post-operatively- Gabapentin 100mg three times daily for POD0-7, ketorolac 10mg four times daily for POD1-5 days, and ondansetron 4mg as needed for nausea; patients will also have a prescription for hydrocodone-acetaminophen 5/325mg tabs that they may fill if needed for emergency/breakthrough pain.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,745 Total Patients Enrolled
4 Trials studying Pain
306 Patients Enrolled for Pain
Jeffrey KenkelPrincipal InvestigatorUT Southwestern
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not severely overweight (BMI less than 40) and you do not smoke.You have had long-lasting pain in the past.You cannot take gabapentin if you have kidney problems, are elderly, or consume alcohol.Your body mass index (BMI) is very high (over 40).You currently smoke cigarettes.Your diabetes is not well controlled.You have a history of using illegal drugs through injection.You cannot take acetaminophen if you have liver or kidney problems, or if you drink alcohol regularly.You are allergic to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen, or acetaminophen.
Research Study Groups:
This trial has the following groups:- Group 1: Current Practice Arm
- Group 2: Enhanced Recovery After Surgery (ERAS) Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies for participants in this clinical trial?
"According to clinicaltrials.gov, the recruitment for this trial has been concluded since its last updating on January 27th 2022. As of now, there are 345 other trials that have open enrollment periods."
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