Liposomal Bupivacaine in Implant Based Breast Reconstruction
NCT ID: NCT02659501
Last Updated: 2021-01-12
Study Results
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View full resultsBasic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2015-07-31
2017-07-31
Brief Summary
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1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
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Detailed Description
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1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.
4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.
Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.
The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bupivacaine with epinephrine injections
Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Bupivacaine with epinephrine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Liposomal bupivacaine
Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam.
Liposomal bupivacaine
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Interventions
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Liposomal bupivacaine
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
Bupivacaine with epinephrine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
Morphine sulfate
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Hydrocodone/acetaminophen
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
Diazepam
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Women with a documented history of hypersensitivity reactions to local-anesthetic agents
* Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
* Women who are currently pregnant
* Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
* Women with impaired hepatic function
18 Years
99 Years
FEMALE
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Subhas Gupta, MD, PhD
Principal Investigator
Principal Investigators
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Subhas C. Gupta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Wendy W. Wong, MD
Role: STUDY_DIRECTOR
Loma Linda University
Locations
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Loma Linda University Health System
Loma Linda, California, United States
Countries
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References
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Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
Wheble GA, Tan EK, Turner M, Durrant CA, Heppell S. Surgeon-administered, intra-operative transversus abdominis plane block in autologous breast reconstruction: a UK hospital experience. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1665-70. doi: 10.1016/j.bjps.2013.07.017. Epub 2013 Jul 31.
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Richard BM, Ott LR, Haan D, Brubaker AN, Cole PI, Nelson KG, Ross PE, Rebelatto MC, Newton PE. The safety and tolerability evaluation of DepoFoam bupivacaine (bupivacaine extended-release liposome injection) administered by incision wound infiltration in rabbits and dogs. Expert Opin Investig Drugs. 2011 Oct;20(10):1327-41. doi: 10.1517/13543784.2011.611499. Epub 2011 Aug 26.
Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.
Other Identifiers
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5150012
Identifier Type: -
Identifier Source: org_study_id
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