Augmentation, Mastopexy, Outpatient Breast Surgery, Revision
Conditions
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
Interventions
DRUGBupivicaine HCl
Ultrasound guided serratus plane block with bupivicaine
DRUGNormal Saline
Same injection technique as intervention arm with normal saline
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Requirements | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain With Numeric Rating Scale | every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours. | * 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. |
| Postoperative Nausea and Vomiting With Verbal Rating Scale | every 30 minutes in the PACU for the first four hours and at hourly intervals up until PACU discharge, up to 10 hours. | 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. |
| Number of Participants Who Required Antiemetics During the Postoperative Period. | 4 to 10 hours | Number of Participants who Required Antiemetics During the Postoperative Period. |
| PACU Length of Stay | 0 to 10 hours | Time to PACU discharge |
| Patient Experience and Satisfaction With a 5-point Categorial Scale | 1 week | 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. |
Countries
United States
Participant flow
Recruitment details
At pre-surgical testing, approximately one week before surgery, potential subjects will be screened and recruited into the trial.
Pre-assignment details
* Any physical, mental or medical condition, makes study participation inadvisable. For example, chronic pain conditions, significant medical disease, laboratory abnormalities or condition(s) that could impact a subject's ability to communicate with the study staff, complete study activities such as provide pain scores, or would otherwise contradict study participation * Patients who are pregnant or nursing. * Patients may withdraw from this study at their discretion.
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine HCl Ultrasound guided serratus plane block with bupivacaine HCl.
Bupivicaine HCl: Ultrasound guided serratus plane block with bupivicaine | 22 |
| Normal Saline Placebo injection on operated side, same technique as experimental group.
Normal Saline: Same injection technique as intervention arm with normal saline | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient experience and satisfaction category lost one patient in each group to follow-up call. | 1 | 1 |
| Overall Study | Subject is a screen failure. Miscommunication with the randomization request. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Bupivicaine HCl | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Continuous | 52.045 years | 49.05 years | 50.62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 12 Participants | 28 Participants |
| Region of Enrollment United States | 22 participants | 20 participants | 42 participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 4 to 10 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | Postoperative Opioid Requirements | 19.875 Morphine Milligram Equivalents (MME) | Standard Deviation 21.93703609496 |
| Normal Saline | Postoperative Opioid Requirements | 17.5 Morphine Milligram Equivalents (MME) | Standard Deviation 22.124052165246 |
Secondary
Number of Participants Who Required Antiemetics During the Postoperative Period.
Number of Participants who Required Antiemetics During the Postoperative Period.
Time frame: 4 to 10 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine HCl | Number of Participants Who Required Antiemetics During the Postoperative Period. | 6 Participants |
| Normal Saline | Number of Participants Who Required Antiemetics During the Postoperative Period. | 5 Participants |
Secondary
PACU Length of Stay
Time to PACU discharge
Time frame: 0 to 10 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | PACU Length of Stay | 115.8 Minutes | Standard Deviation 48.879658884157 |
| Normal Saline | PACU Length of Stay | 144.35 Minutes | Standard Deviation 83.998292589163 |
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.
Time frame: 1 week
Population: One patient in each group (Bupivacaine HCI \& Normal Saline) was missing information on patient satisfaction with pain management.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine HCl | Patient Experience and Satisfaction With a 5-point Categorial Scale | Anesthesia Satisfaction | 4.4210526315789 score on a scale | Standard Deviation 0.6069769786668 |
| Bupivacaine HCl | Patient Experience and Satisfaction With a 5-point Categorial Scale | Surgery Satisfaction | 4.2631578947368 score on a scale | Standard Deviation 0.9911892555667 |
| Normal Saline | Patient Experience and Satisfaction With a 5-point Categorial Scale | Anesthesia Satisfaction | 4 score on a scale | Standard Deviation 1.0540925533894 |
| Normal Saline | Patient Experience and Satisfaction With a 5-point Categorial Scale | Surgery Satisfaction | 4.2105263157894 score on a scale | Standard Deviation 0.6306035352846 |
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. * 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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | Postoperative Nausea and Vomiting With Verbal Rating Scale | 0.2545454545454 score on a scale | Standard Deviation 0.4842899494217 |
| Normal Saline | Postoperative Nausea and Vomiting With Verbal Rating Scale | 0.3363636363636 score on a scale | Standard Deviation 0.8099533063187 |
Secondary
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | Postoperative Pain With Numeric Rating Scale | 0.7818181818181 score on a scale | Standard Deviation 0.8138642058897 |
| Normal Saline | Postoperative Pain With Numeric Rating Scale | 0.7536363636363 score on a scale | Standard Deviation 0.7338097362481 |