Mammaplasty
Conditions
Keywords
breast reconstruction, mammaplasty, analgesic
Brief summary
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.
Detailed description
The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery. The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers believe that this non-opioid based drug could reduce the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.
Interventions
PROCEDUREBreast Reconstruction (Mammaplasty)
Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander
DEVICEPecs blocks
Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.
DRUGExparel
Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.
DRUGBupivacaine
This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.
Sponsors
Pacira Pharmaceuticals, Inc
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient will be randomized into one of the two trial arms. Randomization process will involve 60 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks and 30 which will contain assignment to bupivacaine blocks. The PI's attending nurse will randomly distribute an envelope to the study team between V1 and V2. V2, the day of surgery, will be the only visit where the patient would potentially have contact with the treatments. The patient will not be aware of what treatment they receive until after their 2-week follow-up.
Intervention model description
1. Group 1: Use of Pecs block types I and II with bupivacaine as local anesthetic 2. Group 2: Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects greater than 18 years of age. 2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.
Exclusion criteria
1. Subjects undergoing flap breast reconstruction. 2. Subjects who are undergoing direct-to-implant surgery. 3. Subjects who have previously undergone radiation therapy. 4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 5. Subjects who are pregnant at the date of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 2 weeks post op | • Investigate amount of post-operative opioid consumption post operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | 2 weeks post op | • Assess Post-Operative Nausea scores between the two arms using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten, where ten is the most nausea experienced |
| Mobility | 2 weeks post op | • Assess post-operative mobility using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the most immobile |
| Pain Outcomes | 2 weeks post op | • Assess the pain patients experience throughout their recovery period using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the highest pain |
Countries
United States
Outcome results
None listed