Breast Cancer
Conditions
Keywords
Reconstruction, Bupivacaine, Liposomal Bupivacaine
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 1. 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. 2. 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. 3. Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.
Interventions
DRUGLiposomal Bupivacaine
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.
DRUGBupivacaine
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.
The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
DRUGOral Narcotic
Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Medication utilized will be blinded in the chart per inpatient pharmacy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total post-operative narcotic utilization | Up to 72 hours post-operative | post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| coughing pain score on visual analog scale | Up to 72 hours post-operative | 0-100 score of self-reported pain |
| number of incidents of nausea reported by patient | Up to 72 hours post-operative | self-report of nausea |
| number of incidents of vomiting reported by patient | Up to 72 hours post-operative | number of times a patient vomits |
| at rest pain score on visual analog scale | Up to 72 hours post-operative | 0-100 score of self-reported pain |
| time to first liquid intake | Up to 72 hours post-operative | — |
| time to first solid intake | Up to 72 hours post-operative | — |
| time to first ambulation | Up to 72 hours post-operative | — |
Outcome results
None listed