Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)
- Conditions
- Breast Cancer
- Interventions
- Drug: Paravertebral BlockDrug: Pectoral Nerve Block
- Registration Number
- NCT03152929
- Lead Sponsor
- Spectrum Health Hospitals
- Brief Summary
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.
- Detailed Description
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).
The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 89
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paravertebral Block Paravertebral Block The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block Pectoral Nerve Block The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
- Primary Outcome Measures
Name Time Method Postoperative Narcotic Use First 24 hours post-PACU (or until discharge) Participants for whom Narcotics were used postoperatively
Intraoperative Narcotic Use intraoperatively, average of about 1 hour Participants for whom Narcotics were used for pain during surgery
Post Anesthesia Care Unit (PACU) Narcotic Use in PACU, generally 1-3 hours Participants for whom Narcotics were used in PACU
- Secondary Outcome Measures
Name Time Method Pain Control Measured by Pain Scale 2 weeks postoperative Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.
Pain Control Measured by Length of Operation intraoperative Measuring pain control by how long (in minutes) patient is in surgery
Pain Control Measured by Estimated Blood Loss intraoperative Measuring blood loss (in ml) during surgery
Participants With Postoperative Nausea 2 weeks postoperative count of participants who reported nausea after surgery
Pain Control Measured by the Use of Pain Pills Postoperatively 2 weeks postoperative Participants who used narcotic pain pills postoperatively
Pain Control Measured by Calls to Physicians Office Relating to Pain 2 weeks postoperative Number of phone calls made to physician office regarding pain
Trial Locations
- Locations (1)
Esther L Peariso
🇺🇸Grand Rapids, Michigan, United States