Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy

ID
Name
2016-306
Description
The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.
Trial arms
Trial start
2017-03-09
Estimated PCD
2019-05-21
Trial end
2019-05-21
Status
Terminated
Phase
Early phase I
Treatment
Paravertebral Block
20-30 mL 0.5% Ropivacaine
Arms:
Paravertebral Block
Other names:
PVB
Pectoral Nerve Block
20-30 mL 0.5% Ropivacaine
Arms:
Pectoral Nerve Block
Other names:
PEC
Size
89
Primary endpoint
Intraoperative Narcotic Use
intraoperatively, average of about 1 hour
Post Anesthesia Care Unit (PACU) Narcotic Use
in PACU, generally 1-3 hours
Postoperative Narcotic Use
First 24 hours post-PACU (or until discharge)
Eligibility criteria
Inclusion Criteria: * Female patients ≥ 18 years of age * Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy. * Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia * Patient agrees to participate in the study and signs informed consent Exclusion Criteria: * Neoadjuvant radiation therapy * Stage IV cancer * Previous breast surgery (excluding percutaneous biopsies of all types) * History of either PVB or PEC procedures * Planned general anesthesia use during surgery * Allergies to ropivacaine, midazolam, fentanyl, or propofol * Pregnant women * Prisoners * Adults unable to consent * Non-English-speaking patients
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 89, 'type': 'ACTUAL'}}
Updated at
2023-06-06

1 organization

2 products

1 indication

Organization
Spectrum Health Hospitals
Product
Paravertebral Block
Indication
Breast Cancer
Product
Pectoral Nerve Block