Back to resultsSerratus Plane Block for Postoperative Pain Control
Primary Purpose
Outpatient Breast Surgery, Mastopexy, Augmentation
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivicaine HCl
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Outpatient Breast Surgery
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Northwell Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bupivicaine HCl
Normal Saline
Arm Description
Ultrasound guided serratus plane block with bupivacaine HCl.
Placebo injection on operated side, same technique as experimental group.
Outcomes
Primary Outcome Measures
Postoperative opioid requirements
Secondary Outcome Measures
Postoperative pain with Numeric Rating Scale
Pain assessed at timed intervals at rest and movement during postoperative period.
Incidence of postoperative nausea and vomiting
Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded
Incidence of antiemetic use
The proportion of patients who required antiemetics during the postoperative period.
PACU length of stay
Time to PACU discharge
Patient satisfaction with Likert scale
Patient satisfaction with pain management
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02865928
Brief Title
Serratus Plane Block for Postoperative Pain Control
Official Title
Serratus Plane Block for Postoperative Pain Control After Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outpatient Breast Surgery, Mastopexy, Augmentation, Revision
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivicaine HCl
Arm Type
Experimental
Arm Description
Ultrasound guided serratus plane block with bupivacaine HCl.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Placebo injection on operated side, same technique as experimental group.
Intervention Type
Drug
Intervention Name(s)
Bupivicaine HCl
Other Intervention Name(s)
Bupivicaine
Intervention Description
Ultrasound guided serratus plane block with bupivicaine
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
0.09% NaCl
Intervention Description
Same injection technique as intervention arm with normal saline
Primary Outcome Measure Information:
Title
Postoperative opioid requirements
Time Frame
4 to 10 hours
Secondary Outcome Measure Information:
Title
Postoperative pain with Numeric Rating Scale
Description
Pain assessed at timed intervals at rest and movement during postoperative period.
Time Frame
4 to 10 hours
Title
Incidence of postoperative nausea and vomiting
Description
Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded
Time Frame
4 to 10 hours
Title
Incidence of antiemetic use
Description
The proportion of patients who required antiemetics during the postoperative period.
Time Frame
4 to 10 hours
Title
PACU length of stay
Description
Time to PACU discharge
Time Frame
4 to 10 hours
Title
Patient satisfaction with Likert scale
Description
Patient satisfaction with pain management
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oonagh Dowling, PhD
Phone
718-470-7630
Email
odowling@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Aronsohn, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Aronsohn, MD
First Name & Middle Initial & Last Name & Degree
Oonagh Dowling, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Serratus Plane Block for Postoperative Pain Control
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