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We decided to terminate this study due to staffing changes and other limitations posed by the COVID-19 pandemic.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine HCl | Experimental | Ultrasound guided serratus plane block with bupivacaine HCl. |
|
| Normal Saline | Placebo Comparator | Placebo injection on operated side, same technique as experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivicaine HCl | Drug | Ultrasound guided serratus plane block with bupivicaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain With Numeric Rating Scale |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Aronsohn, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health System | New Hyde Park | New York | 11040 | United States |
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At pre-surgical testing, approximately one week before surgery, potential subjects will be screened and recruited into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivicaine HCl | Ultrasound guided serratus plane block with bupivacaine HCl. Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine |
| FG001 | Normal Saline | Placebo injection on operated side, same technique as experimental group. Normal Saline: Same injection technique as intervention arm with normal saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
At pre-surgical testing, subjects screened will be recruited into the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivicaine HCl | Ultrasound guided serratus plane block with bupivacaine HCl. Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine |
| BG001 | Normal Saline | Placebo injection on operated side, same technique as experimental group. Normal Saline: Same injection technique as intervention arm with normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | 4 to 10 hours |
|
The protocol states that all adverse events occurring during the study period will be recorded. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause. This will occur through study completion, an average of 1 year.
The investigator will seek information on AE by monitoring while subject is under anesthesia, specific questioning and by examination. All related signs, symptoms, and abnormal diagnostic procedures results will be recorded in the source document. All AEs occurring during the study period will be recorded. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause
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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 | Bupivicaine HCl | Ultrasound guided serratus plane block with bupivacaine HCl. Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis Ballas | Northwell Health | 718-470-5827 | lballas@northwell.edu |
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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 | May 14, 2018 | Dec 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2019 | Dec 29, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | Same injection technique as intervention arm with normal saline |
|
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| 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.
| 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. | 4 to 10 hours |
| PACU Length of Stay | Time to PACU discharge | 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. | 1 week |
| Patient experience and satisfaction category lost one patient in each group to follow-up call. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Postoperative Pain With Numeric Rating Scale |
| Posted | Mean | Standard Deviation | score on a scale | every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours. |
|
|
|
| Secondary | Postoperative Nausea and Vomiting With Verbal Rating Scale | Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded.
| Posted | Mean | Standard Deviation | score on a scale | every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours. |
|
|
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| Secondary | Number of Participants Who Required Antiemetics During the Postoperative Period. | Number of Participants who Required Antiemetics During the Postoperative Period. | Posted | Count of Participants | Participants | 4 to 10 hours |
|
|
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| Secondary | PACU Length of Stay | Time to PACU discharge | Posted | Mean | Standard Deviation | Minutes | 0 to 10 hours |
|
|
|
| Secondary | 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. | One patient in each group (Bupivacaine HCI & Normal Saline) was missing information on patient satisfaction with pain management. | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Normal Saline | Placebo injection on operated side, same technique as experimental group. Normal Saline: Same injection technique as intervention arm with normal saline | 0 | 20 | 0 | 20 | 0 | 20 |
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