Breast CancerPhase 3NCT03152929
Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)
A Phase 3 study testing Paravertebral Block and Pectoral Nerve Block in people with Breast Cancer, run by Corewell Health West at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paravertebral Block and Pectoral Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 21 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnant women
- Prisoners
- Adults unable to consent
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Paravertebral Block, Pectoral Nerve Block
- Keywords
- Surgery, Breast, Pectoral Nerve Block, Paravertebral Block, Analgesia, Mastectomy
- Medical subject headings
- Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral BlockDrug
Also called PVB
20-30 mL 0.5% Ropivacaine
Pectoral Nerve BlockDrug
Also called PEC
20-30 mL 0.5% Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Active comparator | The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Receives: Drug: Paravertebral Block |
| 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) Receives: Drug: Pectoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Narcotic Use
Participants for whom Narcotics were used for pain during surgery
Measured: intraoperatively, average of about 1 hour
Post Anesthesia Care Unit (PACU) Narcotic Use
Participants for whom Narcotics were used in PACU
Measured: in PACU, generally 1-3 hours
Postoperative Narcotic Use
Participants for whom Narcotics were used postoperatively
Measured: First 24 hours post-PACU (or until discharge)
Secondary outcomes (6)
Pain Control Measured by Length of Operation
Measuring pain control by how long (in minutes) patient is in surgery
Measured: intraoperative
Pain Control Measured by Estimated Blood Loss
Measuring blood loss (in ml) during surgery
Measured: intraoperative
Participants With Postoperative Nausea
count of participants who reported nausea after surgery
Measured: 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.
Measured: 2 weeks postoperative
Pain Control Measured by the Use of Pain Pills Postoperatively
Participants who used narcotic pain pills postoperatively
Measured: 2 weeks postoperative
Pain Control Measured by Calls to Physicians Office Relating to Pain
Number of phone calls made to physician office regarding pain
Measured: 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start9 Mar 2017
- Primary completion21 May 2019
- Study completion21 May 2019
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne Melink, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152929
- Sponsor's protocol ID
- 2016-306
- Status last verified
- Jun 2023
- First submitted
- 1 Mar 2017
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy
- ClinicalTrials.gov ID
- NCT03152929
- Acronym / sponsor ID
- 2016-306
- Conditions
- Breast Cancer
- Keywords
- Surgery, Breast, Pectoral Nerve Block, Paravertebral Block, Analgesia, Mastectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Active comparator | Drug: Paravertebral BlockThe Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) |
| Pectoral Nerve Block | Active comparator | Drug: Pectoral Nerve BlockThe Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral BlockAlso: PVB20-30 mL 0.5% Ropivacaine | Drug | Paravertebral Block |
| Pectoral Nerve BlockAlso: PEC20-30 mL 0.5% Ropivacaine | Drug | Pectoral Nerve Block |
Primary outcome
Intraoperative Narcotic Use
Time frame: intraoperatively, average of about 1 hour
Participants for whom Narcotics were used for pain during surgery
Post Anesthesia Care Unit (PACU) Narcotic Use
Time frame: in PACU, generally 1-3 hours
Participants for whom Narcotics were used in PACU
Postoperative Narcotic Use
Time frame: First 24 hours post-PACU (or until discharge)
Participants for whom Narcotics were used postoperatively
6 secondary outcomes
Pain Control Measured by Length of Operation
Time frame: intraoperative
Pain Control Measured by Estimated Blood Loss
Time frame: intraoperative
Participants With Postoperative Nausea
Time frame: 2 weeks postoperative
Pain Control Measured by Pain Scale
Time frame: 2 weeks postoperative
Pain Control Measured by the Use of Pain Pills Postoperatively
Time frame: 2 weeks postoperative
Pain Control Measured by Calls to Physicians Office Relating to Pain
Time frame: 2 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Melink, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paravertebral Block and Pectoral Nerve Block in people with Breast Cancer, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Narcotic Use (time frame: intraoperatively, average of about 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.