Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.

Detailed Description
-----------------
This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy. OBJECTIVES Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block. Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake. Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.

Official Title
-----------------
Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Liposomal Bupivacaine
* Drug: Bupivacaine
* Drug: Patient-Controlled Analgesia Pump
* Drug: Oral Narcotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to have a unilateral, immediate breast reconstruction Exclusion Criteria: Pregnant Concurrent or recent medical condition that could interfere with study participation including: Hepatitis Alcohol/substance abuse Uncontrolled psychiatric disorders Known allergy Contraindication to amide-type local anesthetics, opioids, or propofol. Body weight of less than 50 kg Participated in another study involving an investigational medication within the prior 30 days Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine + Bupivacaine<br>This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. | Drug: Liposomal Bupivacaine<br>* 20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.<br>* Other names: Exparel;Drug: Bupivacaine<br>* 20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.<br>* Other names: Bupivacaine Spinal;Drug: Patient-Controlled Analgesia Pump<br>* The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.<br>* Other names: intravenous narcotic;Drug: Oral Narcotic<br>* Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.<br>|
| Active Comparator: Bupivacaine<br>This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. | Drug: Bupivacaine<br>* 20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.<br>* Other names: Bupivacaine Spinal;Drug: Patient-Controlled Analgesia Pump<br>* The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.<br>* Other names: intravenous narcotic;Drug: Oral Narcotic<br>* Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total post-operative narcotic utilization | post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine. | Up to 72 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| at rest pain score on visual analog scale | 0-100 score of self-reported pain | Up to 72 hours post-operative | 
| coughing pain score on visual analog scale | 0-100 score of self-reported pain | Up to 72 hours post-operative | 
| number of incidents of nausea reported by patient | self-report of nausea | Up to 72 hours post-operative | 
| number of incidents of vomiting reported by patient | number of times a patient vomits | Up to 72 hours post-operative | 
| time to first ambulation |  | Up to 72 hours post-operative | 
| time to first liquid intake |  | Up to 72 hours post-operative | 
| time to first solid intake |  | Up to 72 hours post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bupivacaine, Reconstruction, Liposomal Bupivacaine