Serratus Plane Block for Postoperative Pain Control

Study Overview
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Brief Summary
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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

Official Title
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Serratus Plane Block for Postoperative Pain Control After Breast Surgery

Conditions
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Mastopexy, Outpatient Breast Surgery, Augmentation, Revision

Intervention / Treatment
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* Drug: Bupivicaine HCl
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine HCl<br>Ultrasound guided serratus plane block with bupivacaine HCl. | Drug: Bupivicaine HCl<br>* Ultrasound guided serratus plane block with bupivicaine<br>* Other names: Bupivicaine;|
| Placebo Comparator: Normal Saline<br>Placebo injection on operated side, same technique as experimental group. | Drug: Normal Saline<br>* Same injection technique as intervention arm with normal saline<br>* Other names: 0.09% NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid requirements |  | 4 to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain with Numeric Rating Scale | Pain assessed at timed intervals at rest and movement during postoperative period. | 4 to 10 hours | 
| Incidence of postoperative nausea and vomiting | Nausea assessed at time intervals with numeric rating scale and episodes of vomiting and retching recorded | 4 to 10 hours | 
| Incidence of antiemetic use | The proportion of patients who required antiemetics during the postoperative period. | 4 to 10 hours | 
| PACU length of stay | Time to PACU discharge | 4 to 10 hours | 
| Patient satisfaction with Likert scale | Patient satisfaction with pain management | 1 week |