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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander
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.
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.
Northwestern Memorial Hospital
Chicago, Illinois, United States
Opioid consumption
• Investigate amount of post-operative opioid consumption post operatively
Time frame: 2 weeks post op
Nausea
• 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
Time frame: 2 weeks post op
Mobility
• 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
Time frame: 2 weeks post op
Pain Outcomes
• 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
Time frame: 2 weeks post op
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This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in both arms.