TerminatedPhase 4

Serratus Plane Block for Postoperative Pain Control

Stopped: We decided to terminate this study due to staffing changes and other limitations posed by the COVID-19 pandemic.

United States42 participantsStarted 2017-09-05

Plain-language summary

This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I-III. * Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision. Exclusion Criteria: * Unable to provide informed consent. * Patients who are pregnant or nursing. * ASA IV-V. * Alcohol or narcotic dependence in the last 2 years. * Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator. * Hepatic disease. * Allergies to amide anesthetics as determined from medical history or patient self-report. * Evidence of infection at injection site. * Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol. * Body weight \<50kg. * BMI\>40kg/m2. * History of hypotension. * Abnormal renal (creatinine \> 1.5 mg/dL) function. * Heart block. * Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Opioid Requirements

Timeframe: 4 to 10 hours

Trial details

NCT IDNCT02865928

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-25

Results submitted2023-01-26

View on ClinicalTrials.gov More Outpatient Breast Surgery trials