MastectomyPhase 4NCT03143530
Effect of Pectoralis Block on Analgesia After Simple Mastectomy
A Phase 4 study testing Pectoralis block, Normal saline injection and Ropivacaine Injection in people with Mastectomy and Nerve Block, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy, Nerve Block, Analgesia, Postoperative
- What is being tested?
- Pectoralis block, Normal saline injection and Ropivacaine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2017to 1 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
- Patients undergoing simple mastectomy
Who cannot join
- -Patient Refusal
- Allergy to local anesthetics
- Inability to communicate in English
- Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery
- Existing nerve injuries or sensory deficits
- Conversion to anesthesia via an endotracheal tube
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: The Effect of Pectoralis Block on Analgesia After Simple Mastectomy
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
Read the detailed description
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
- Conditions
- Mastectomy, Nerve Block, Analgesia, Postoperative
- Being tested
- Pectoralis block, Normal saline injection, Ropivacaine Injection
- Keywords
- Ropivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoralis blockProcedure or surgery
Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).
Normal saline injectionDrug
Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
Ropivacaine InjectionDrug
Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
| Study group | Role | What they receive |
|---|---|---|
| Pectoralis Block with Ropivacaine | Active comparator | General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg) Receives: Procedure: Pectoralis block; Drug: Ropivacaine Injection |
| Pectoralis Block with normal saline | Placebo comparator | General anesthesia + Pectoralis block with 30ml of normal saline injection Receives: Procedure: Pectoralis block; Drug: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-27 score at baseline
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Measured: Baseline
Quality of Recovery-27 score at post operative day 1
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1
Measured: Post operative day 1
Quality of Recovery-27 scores at post operative day 7
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7
Measured: Post operative day 7
Quality of Recovery-27 scores at post operative day 30
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30
Measured: Post operative day 30
Quality of Recovery-27 scores at post operative day 90
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90
Measured: Post operative day 90
Secondary outcomes (3)
Comparison of Numerical Rating Scale-11 (NRS-11) at rest
Comparison of patient reported pain assessment while at rest using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain.
Measured: 90 days
Comparison of Numerical Rating Scale-11 (NRS-11) with movement
Comparison of patient reported pain assessment while with movement using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain.
Measured: 90 days
Duration of postoperative analgesia
Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startDec 2017 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Why it stopped: Extensive protocol revisions initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two of the following groups for the duration of the study. 1. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg) 2. General anesthesia + sham block with 30ml of normal saline
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Uma Shastri, Vanderbilt University Medical Center
- Investigators
- Uma Shastri, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143530
- Sponsor's protocol ID
- 160419
- Status last verified
- Aug 2018
- First submitted
- 20 Mar 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- 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 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pectoralis Block on Analgesia After Simple Mastectomy
- ClinicalTrials.gov ID
- NCT03143530
- Acronym / sponsor ID
- 160419
- Conditions
- Mastectomy, Nerve Block, Analgesia, Postoperative
- Keywords
- Ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Extensive protocol revisions initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Dec 2017 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
Detailed description
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two of the following groups for the duration of the study. 1. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg) 2. General anesthesia + sham block with 30ml of normal saline
| Arm | Type | Receives |
|---|---|---|
| Pectoralis Block with Ropivacaine | Active comparator | Procedure: Pectoralis block, Drug: Ropivacaine InjectionGeneral anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg) |
| Pectoralis Block with normal saline | Placebo comparator | Procedure: Pectoralis block, Drug: Normal saline injectionGeneral anesthesia + Pectoralis block with 30ml of normal saline injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
- Patients undergoing simple mastectomy
Key exclusion criteria (6 listed)
- -Patient Refusal
- Allergy to local anesthetics
- Inability to communicate in English
- Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery
- Existing nerve injuries or sensory deficits
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 |
|---|---|---|
| Pectoralis blockPectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). | Procedure or surgery | Pectoralis Block with Ropivacaine, Pectoralis Block with normal saline |
| Normal saline injectionPectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior | Drug | Pectoralis Block with normal saline |
| Ropivacaine InjectionPectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior | Drug | Pectoralis Block with Ropivacaine |
Primary outcome
Quality of Recovery-27 score at baseline
Time frame: Baseline
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Quality of Recovery-27 score at post operative day 1
Time frame: Post operative day 1
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1
Quality of Recovery-27 scores at post operative day 7
Time frame: Post operative day 7
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7
Quality of Recovery-27 scores at post operative day 30
Time frame: Post operative day 30
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30
Quality of Recovery-27 scores at post operative day 90
Time frame: Post operative day 90
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90
3 secondary outcomes
Comparison of Numerical Rating Scale-11 (NRS-11) at rest
Time frame: 90 days
Comparison of Numerical Rating Scale-11 (NRS-11) with movement
Time frame: 90 days
Duration of postoperative analgesia
Time frame: Up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- 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.
Uma Shastri, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pectoralis block, Normal saline injection and Ropivacaine Injection in people with Mastectomy and Nerve Block, run by Vanderbilt University Medical Center 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Aug 2018. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quality of Recovery-27 score at baseline (time frame: Baseline). The study lists 5 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 14 Aug 2018.