Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Paravertebral Block
* Drug: Pectoral Nerve Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral Block<br>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) | Drug: Paravertebral Block<br>* 20-30 mL 0.5% Ropivacaine<br>* Other names: PVB;|
| Active Comparator: Pectoral Nerve Block<br>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) | Drug: Pectoral Nerve Block<br>* 20-30 mL 0.5% Ropivacaine<br>* Other names: PEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Narcotic Use | Participants for whom Narcotics were used for pain during surgery | intraoperatively, average of about 1 hour | 
| Post Anesthesia Care Unit (PACU) Narcotic Use | Participants for whom Narcotics were used in PACU | in PACU, generally 1-3 hours | 
| Postoperative Narcotic Use | Participants for whom Narcotics were used postoperatively | First 24 hours post-PACU (or until discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Control Measured by Length of Operation | Measuring pain control by how long (in minutes) patient is in surgery | intraoperative | 
| Pain Control Measured by Estimated Blood Loss | Measuring blood loss (in ml) during surgery | intraoperative | 
| Participants With Postoperative Nausea | count of participants who reported nausea after surgery | 2 weeks postoperative | 
| Pain Control Measured by Pain Scale | Pain measured on scale of one to ten, one being least amount of pain and ten the greatest. | 2 weeks postoperative | 
| Pain Control Measured by the Use of Pain Pills Postoperatively | Participants who used narcotic pain pills postoperatively | 2 weeks postoperative | 
| Pain Control Measured by Calls to Physicians Office Relating to Pain | Number of phone calls made to physician office regarding pain | 2 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Breast, Pectoral Nerve Block, Paravertebral Block, Analgesia, Mastectomy