Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2019 |
| Start Date: | April 2019 |
| End Date: | December 2019 |
| Contact: | Risal Djohan, MD |
| Email: | DJOHANR@ccf.org |
| Phone: | 440-878-2500 |
Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
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.
breast pain for patients undergoing a unilateral, immediate breast reconstruction.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
