WithdrawnPhase 4

Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies

Stopped: Critical study personnel left the institution

United States0Started 2018-12

Plain-language summary

HYPOTHESIS Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies. SPECIFIC AIMS Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.

Who can participate

Age range

18 Years – 80 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: * Simple or radical unilateral mastectomy with or without axillary lymph node dissection. * American Society of Anesthesia (ASA) I, II and III Exclusion Criteria: * Morbid obesity (body mass index \> 40 kg/m2); * Renal insufficiency (creatinine \> 2.0 mg/DL), * Current chronic analgesic therapy (daily use \> 4 weeks), * History of opioid dependence, pregnancy. * Allergy to local anesthetic * Rash/infection at the area of injection * Coagulation disorder * Patients on anticoagulation

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

Efficacy of SPB block vs thoracic PVB

Timeframe: 6 months

Trial details

NCT IDNCT02822196

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

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