Outpatient Breast SurgeryPhase 4NCT02865928
Serratus Plane Block for Postoperative Pain Control
A Phase 4 study testing Bupivicaine HCl and Normal Saline in people with Outpatient Breast Surgery and Mastopexy, run by Northwell Health at 1 site in United States.
Trial summary
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Outpatient Breast Surgery, Mastopexy, Augmentation
- What is being tested?
- Bupivicaine HCl and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 25 Nov 2019
- Phase
- Phase 4
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III.
- Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.
Who cannot join
- Unable to provide informed consent.
- Patients who are pregnant or nursing.
- ASA IV-V.
- Alcohol or narcotic dependence in the last 2 years.
- Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
- Hepatic disease.
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- Allergies to amide anesthetics as determined from medical history or patient self-report.
- Evidence of infection at injection site.
- Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol.
- Body weight <50kg.
- BMI>40kg/m2.
- History of hypotension.
- Abnormal renal (creatinine > 1.5 mg/dL) function.
- Heart block.
- Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health System
New Hyde Park, New York, 11040
About this study
Official title: Serratus Plane Block for Postoperative Pain Control After Breast Surgery
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction
- Conditions
- Outpatient Breast Surgery, Mastopexy, Augmentation, Revision
- Being tested
- Bupivicaine HCl, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivicaine HClDrug
Also called Bupivicaine
Ultrasound guided serratus plane block with bupivicaine
Normal SalineDrug
Also called 0.09% NaCl
Same injection technique as intervention arm with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Bupivicaine HCl | Experimental | Ultrasound guided serratus plane block with bupivacaine HCl. Receives: Drug: Bupivicaine HCl |
| Normal Saline | Placebo comparator | Placebo injection on operated side, same technique as experimental group. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Requirements
Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.
Measured: 4 to 10 hours
Secondary outcomes (5)
Postoperative Pain With Numeric Rating Scale
- Postoperatively, pain intensities at rest and on movement will be assessed every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, using the visual analog scale (VAS) with two anchor points; 0 being no pain and 10 being the worst pain imaginable. Pain scores were combined to find the mean and standard deviation.
- The study will collect pain and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.
Measured: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Postoperative Nausea and Vomiting With Verbal Rating Scale
Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded.
- Evaluation will be performed at every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge using a standard 11-point verbal rating scale, for which "0" represents "no nausea" and 10 represents "worst nausea imaginable." Nausea and vomiting scores were combined to find the mean and standard deviation.
- The study will collect nausea and scores in the PACU every 30 minutes up to 4 hrs and at 1 hr intervals after 4 hours for the duration of PACU stay.
Measured: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Number of Participants Who Required Antiemetics During the Postoperative Period.
Number of Participants who Required Antiemetics During the Postoperative Period.
Measured: 4 to 10 hours
PACU Length of Stay
Time to PACU discharge
Measured: 0 to 10 hours
Patient Experience and Satisfaction With a 5-point Categorial Scale
This survey assessed patient experience and satisfaction. The scale ranged from "Very dissatisfied" or "1" was the minimum value. "Very satisfied" or "5" was the maximum value.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start5 Sep 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Why it stopped: We decided to terminate this study due to staffing changes and other limitations posed by the COVID-19 pandemic.
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 Outpatient Breast SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Aronsohn, MD, Northwell Health
- Investigators
- Judith Aronsohn, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865928
- Sponsor's protocol ID
- 15-246
- Status last verified
- Feb 2024
- First submitted
- 28 Jun 2016
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Plane Block for Postoperative Pain Control After Breast Surgery
- ClinicalTrials.gov ID
- NCT02865928
- Acronym / sponsor ID
- 15-246
- Conditions
- Outpatient Breast Surgery, Mastopexy, Augmentation, Revision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We decided to terminate this study due to staffing changes and other limitations posed by the COVID-19 pandemic.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivicaine HCl | Experimental | Drug: Bupivicaine HClUltrasound guided serratus plane block with bupivacaine HCl. |
| Normal Saline | Placebo comparator | Drug: Normal SalinePlacebo injection on operated side, same technique as experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III.
- Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.
Key exclusion criteria (15 listed)
- Unable to provide informed consent.
- Patients who are pregnant or nursing.
- ASA IV-V.
- Alcohol or narcotic dependence in the last 2 years.
- Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
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 |
|---|---|---|
| Bupivicaine HClAlso: BupivicaineUltrasound guided serratus plane block with bupivicaine | Drug | Bupivicaine HCl |
| Normal SalineAlso: 0.09% NaClSame injection technique as intervention arm with normal saline | Drug | Normal Saline |
Primary outcome
Postoperative Opioid Requirements
Time frame: 4 to 10 hours
Postoperatively, oral and IV rescue medication will be administered to both groups upon request as per standard of care. The use of narcotics will also be recorded intra-operatively, for the duration of PACU and hospital stay and up until the end of postoperative day one. Consumption of rescue medication will be converted to the morphine equivalent (ME) dose for analysis.
5 secondary outcomes
Postoperative Pain With Numeric Rating Scale
Time frame: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Postoperative Nausea and Vomiting With Verbal Rating Scale
Time frame: every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours.
Number of Participants Who Required Antiemetics During the Postoperative Period.
Time frame: 4 to 10 hours
PACU Length of Stay
Time frame: 0 to 10 hours
Patient Experience and Satisfaction With a 5-point Categorial Scale
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Post Operative Pain, Opioid Analgesic Adverse Reaction
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.
Judith Aronsohn, MD principal investigator
Northwell Health
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 Bupivicaine HCl and Normal Saline in people with Outpatient Breast Surgery and Mastopexy, run by Northwell Health 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 15 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 22 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2024). 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?
Postoperative Opioid Requirements (time frame: 4 to 10 hours). 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 22 Feb 2024.