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Standards of care changed at the institution so that PEC procedures were no longer common or preferred as a method of pain control for breast surgery.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral Block | Active Comparator | The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) |
|
| Pectoral Nerve Block | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral Block | Drug | 20-30 mL 0.5% Ropivacaine |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Melink, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esther L Peariso | Grand Rapids | Michigan | 49503 | United States |
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enrollment was stopped prematurely as the Standard of Care changed due to rising evidence during the enrollment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Pectoral Nerve Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Narcotic Use | Participants for whom Narcotics were used for pain during surgery | Posted | Count of Participants | Participants | intraoperatively, average of about 1 hour |
|
Adverse events were collected from the time of surgery until the 2 week post op appointment
pain was not considered an adverse event unless it reached a grade 3 by CTCAE v4.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Study was terminated early due to clinical practice outpacing the science of the trial. At the time of stopping enrollment, pectoral nerve blocks were being used standardly. Therefore, we could not ethically continue to randomize patients to both arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Melnik | Spectrum Health | 616-486-6333 | marianne.melnik@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2018 | Feb 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
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| Pectoral Nerve Block | Drug | 20-30 mL 0.5% Ropivacaine |
|
|
| 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 |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Post Anesthesia Care Unit (PACU) Narcotic Use | Participants for whom Narcotics were used in PACU | Posted | Count of Participants | Participants | in PACU, generally 1-3 hours |
|
|
|
| Primary | Postoperative Narcotic Use | Participants for whom Narcotics were used postoperatively | Posted | Count of Participants | Participants | First 24 hours post-PACU (or until discharge) |
|
|
|
| Secondary | Pain Control Measured by Length of Operation | Measuring pain control by how long (in minutes) patient is in surgery | Posted | Mean | Standard Deviation | minutes | intraoperative |
|
|
|
| Secondary | Pain Control Measured by Estimated Blood Loss | Measuring blood loss (in ml) during surgery | Posted | Mean | Standard Deviation | milliliters | intraoperative |
|
|
|
| Secondary | Participants With Postoperative Nausea | count of participants who reported nausea after surgery | Paravertebral population had one non-reporting participant | Posted | Count of Participants | Participants | 2 weeks postoperative |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks postoperative |
|
|
|
| Secondary | Pain Control Measured by the Use of Pain Pills Postoperatively | Participants who used narcotic pain pills postoperatively | Paravertebral Block arm had one participant with no response | Posted | Count of Participants | Participants | 2 weeks postoperative |
|
|
|
| Secondary | Pain Control Measured by Calls to Physicians Office Relating to Pain | Number of phone calls made to physician office regarding pain | one participant in each arm did not have a response recorded | Posted | Count of Participants | Participants | 2 weeks postoperative |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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 | 0 | 49 | 0 | 49 | 0 | 49 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |