Breast Cancer
Conditions
Keywords
Surgery, Breast, Pectoral Nerve Block, Paravertebral Block, Analgesia, Mastectomy
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.
Interventions
DRUGParavertebral Block
20-30 mL 0.5% Ropivacaine
20-30 mL 0.5% Ropivacaine
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Postoperative Narcotic Use | First 24 hours post-PACU (or until discharge) | Participants for whom Narcotics were used postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
United States
Participant flow
Pre-assignment details
enrollment was stopped prematurely as the Standard of Care changed due to rising evidence during the enrollment period.
Participants by arm
| Arm | Count |
|---|---|
| Paravertebral Block The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
Paravertebral Block: 20-30 mL 0.5% Ropivacaine | 40 |
| 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)
Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine | 49 |
| Total | 89 |
Baseline characteristics
| Characteristic | Paravertebral Block | Total | Pectoral Nerve Block |
|---|---|---|---|
| Age, Continuous | 65.15 years STANDARD_DEVIATION 10.18 | 64.65 years STANDARD_DEVIATION 10.83 | 64.24 years STANDARD_DEVIATION 11.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 87 Participants | 48 Participants |
| Region of Enrollment United States | 40 participants | 89 participants | 49 participants |
| Sex: Female, Male Female | 40 Participants | 89 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 49 |
| other Total, other adverse events | 0 / 40 | 0 / 49 |
| serious Total, serious adverse events | 0 / 40 | 0 / 49 |
Outcome results
Primary
Intraoperative Narcotic Use
Participants for whom Narcotics were used for pain during surgery
Time frame: intraoperatively, average of about 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block | Intraoperative Narcotic Use | 26 Participants |
| Pectoral Nerve Block | Intraoperative Narcotic Use | 29 Participants |
Primary
Post Anesthesia Care Unit (PACU) Narcotic Use
Participants for whom Narcotics were used in PACU
Time frame: in PACU, generally 1-3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block | Post Anesthesia Care Unit (PACU) Narcotic Use | 20 Participants |
| Pectoral Nerve Block | Post Anesthesia Care Unit (PACU) Narcotic Use | 33 Participants |
Primary
Postoperative Narcotic Use
Participants for whom Narcotics were used postoperatively
Time frame: First 24 hours post-PACU (or until discharge)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block | Postoperative Narcotic Use | 3 Participants |
| Pectoral Nerve Block | Postoperative Narcotic Use | 1 Participants |
Secondary
Pain Control Measured by Calls to Physicians Office Relating to Pain
Number of phone calls made to physician office regarding pain
Time frame: 2 weeks postoperative
Population: one participant in each arm did not have a response recorded
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paravertebral Block | Pain Control Measured by Calls to Physicians Office Relating to Pain | no phone calls to physician office regarding pain | 38 Participants |
| Paravertebral Block | Pain Control Measured by Calls to Physicians Office Relating to Pain | 1 phone call to physician office regarding pain | 1 Participants |
| Pectoral Nerve Block | Pain Control Measured by Calls to Physicians Office Relating to Pain | no phone calls to physician office regarding pain | 44 Participants |
| Pectoral Nerve Block | Pain Control Measured by Calls to Physicians Office Relating to Pain | 1 phone call to physician office regarding pain | 4 Participants |
Secondary
Pain Control Measured by Estimated Blood Loss
Measuring blood loss (in ml) during surgery
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Pain Control Measured by Estimated Blood Loss | 10.85 milliliters | Standard Deviation 8.3 |
| Pectoral Nerve Block | Pain Control Measured by Estimated Blood Loss | 13.8 milliliters | Standard Deviation 12.29 |
Secondary
Pain Control Measured by Length of Operation
Measuring pain control by how long (in minutes) patient is in surgery
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Pain Control Measured by Length of Operation | 61.80 minutes | Standard Deviation 16.42 |
| Pectoral Nerve Block | Pain Control Measured by Length of Operation | 64.14 minutes | Standard Deviation 20.2 |
Secondary
Pain Control Measured by Pain Scale
Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.
Time frame: 2 weeks postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Pain Control Measured by Pain Scale | 2 score on a scale | Standard Deviation 1.33 |
| Pectoral Nerve Block | Pain Control Measured by Pain Scale | 2.4 score on a scale | Standard Deviation 1.4 |
Secondary
Pain Control Measured by the Use of Pain Pills Postoperatively
Participants who used narcotic pain pills postoperatively
Time frame: 2 weeks postoperative
Population: Paravertebral Block arm had one participant with no response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block | Pain Control Measured by the Use of Pain Pills Postoperatively | 20 Participants |
| Pectoral Nerve Block | Pain Control Measured by the Use of Pain Pills Postoperatively | 24 Participants |
Secondary
Participants With Postoperative Nausea
count of participants who reported nausea after surgery
Time frame: 2 weeks postoperative
Population: Paravertebral population had one non-reporting participant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paravertebral Block | Participants With Postoperative Nausea | 0 Participants |
| Pectoral Nerve Block | Participants With Postoperative Nausea | 1 Participants |