The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

Study Overview
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Brief Summary
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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
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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 hope to show that this non-opioid based drug successfully reduces the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery. The reason the project has three different groups in this study is to show if each group has different outcomes. First, the project hopes to see a difference between the Pecs blocks and normal anesthesia delivery. Then, researchers hope to see a difference between the two Pecs blocks group where the use of Exparel will result in less narcotic use, pain, nausea, and increase mobility.

Official Title
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A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery

Conditions
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Mammaplasty

Intervention / Treatment
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* Procedure: Breast Reconstruction (Mammaplasty)
* Device: Pecs blocks
* Drug: Exparel
* Drug: Bupivacaine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects greater than 18 years of age. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery. Exclusion Criteria: Subjects undergoing flap breast reconstruction. Subjects who are undergoing direct-to-implant surgery. Subjects who have previously undergone radiation therapy. 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. Subjects who are pregnant at the date of surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 (Control): Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol) Group 2: Use of Pecs block types I and II with bupivacaine as local anesthetic Group 3: 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravenous lidocaine<br>Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol) | Procedure: Breast Reconstruction (Mammaplasty)<br>* Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander<br>Drug: Lidocaine<br>* This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arm 1.<br>|
| Active Comparator: Blocks+Bupivacaine<br>Use of Pecs block types I and II with bupivacaine as local anesthetic | Procedure: Breast Reconstruction (Mammaplasty)<br>* Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander<br>Device: Pecs blocks<br>* 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.<br>* Other names: Pecs blocks I and II;Drug: Bupivacaine<br>* This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.<br>|
| Experimental: Blocks+Bupivacaine+Exparel<br>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) | Procedure: Breast Reconstruction (Mammaplasty)<br>* Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander<br>Device: Pecs blocks<br>* 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.<br>* Other names: Pecs blocks I and II;Drug: Exparel<br>* 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.<br>Drug: Bupivacaine<br>* This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | • Investigate amount of post-operative opioid consumption post operatively | 2 weeks post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | • Assess Post-Operative Nausea scores among the three 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 | 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 | 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 | 2 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, mammaplasty, analgesic