Clinical trial NCT03152929: Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)
Official title: Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Surgery
Breast
Pectoral Nerve Block
Paravertebral Block
Analgesia
Mastectomy
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intraoperative Narcotic Use
timeFrame: intraoperatively, average of about 1 hour
measure: Post Anesthesia Care Unit (PACU) Narcotic Use
timeFrame: in PACU, generally 1-3 hours
measure: Postoperative Narcotic Use
timeFrame: First 24 hours post-PACU (or until discharge)
Secondary outcomes:
measure: Pain Control Measured by Length of Operation
timeFrame: intraoperative
measure: Pain Control Measured by Estimated Blood Loss
timeFrame: intraoperative
measure: Participants With Postoperative Nausea
timeFrame: 2 weeks postoperative
measure: Pain Control Measured by Pain Scale
timeFrame: 2 weeks postoperative
measure: Pain Control Measured by the Use of Pain Pills Postoperatively
timeFrame: 2 weeks postoperative
measure: Pain Control Measured by Calls to Physicians Office Relating to Pain
timeFrame: 2 weeks postoperative
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Esther L Peariso
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Marianne Melink, MD
role: PRINCIPAL_INVESTIGATOR
References: