Paravertebral Versus Pectoralis Block for Post Mastectomy Pain (NCT03656679) | Clinical Trial Compass
TerminatedNot Applicable
Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
Stopped: insufficient participant population per COVID-19
United States18 participantsStarted 2018-10-18
Plain-language summary
Post-mastectomy pain affects more than half of patients undergoing the procedure and can last for years. It has been well established that development of chronic pain is related to experienced pain in the perioperative period. This study therefore aims to assess if both acute and chronic post-operative mastectomy pain can be better managed by a novel regional anesthesia nerve block known as the pectoralis block (PECs). The PECs block is easier for patients to position for placement, has less risk of harm to nearby structures, and less risk for systemic uptake of local anesthetic in comparison to the paravertebral block. The PECs block has a strong safety profile. Standard of care at University of Wisconsin (UW) hospital is to utilize regional anesthesia for post op pain management. While PVB is performed on a regular basis at UW per surgeon request, Surgeon can request for PECS block in patients where a PVB was contraindicated (ie. coagulation issues). PECS is in fact the standard of care at other hospitals. This study will assess outcomes in the post anesthetic care unit (PACU), post-operative day 1, 7 and 30.
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:
* The clinical decision has been made that the patient will have a bilateral mastectomy with tissue expander placement
* The participant is ≥ 18 years and ≤ 80 years
* Weight ≥ 60 kg and ≤ 90 kg
* The participant's primary anesthesia care team has planned for general anesthesia
* The participant agrees to receive a regional block
* American Society of Anesthesiologists class 1-3
Exclusion Criteria:
* 18 years of age or \>80 years of age
* \< 60 kg or \> 90 kg
* Non-English speaking
* Known or believed to be pregnant
* Participant is a prisoner
* Participant has impaired decision-making capacity per discretion of the Investigator
* Standard contraindications to regional blocks (coagulopathy including abnormal INR after discontinuation of warfarin, baseline INR (international normalized ratio) \>1.5, platelets \<100,000, elevated PTT (prothrombin time), failure to discontinue anticoagulant medication, or infection at site)
* Significant renal, cardiac or hepatic disease per discretion of the investigator
* A clinical decision made that indicates need for a partial or complete axillary node dissection
* American Society of Anesthesiologists class 4-5
* Known hypersensitivity and/or allergies to local anesthetics
* Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months)
* Participant refusal
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.