Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
3 participants
INTERVENTIONAL
2018-06-14
2020-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bupivacaine Group
Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
Bupivacaine
While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Liposomal Bupivacaine Group
Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
Liposomal Bupivacaine
While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Interventions
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Bupivacaine
While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Liposomal Bupivacaine
While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
* Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.
Exclusion Criteria
* Patients who receive a unilateral reconstruction.
* Patients who are expected to undergo axillary lymph node dissection
* Patients who have undergone breast irradiation
* Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
* Patients who are wards of the state
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
* Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
* Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
* Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
* Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
18 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Christopher M Runyan, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Lovecchio F, Jordan SW, Lim S, Fine NA, Kim JY. Risk Factors for Complications Differ Between Stages of Tissue-Expander Breast Reconstruction. Ann Plast Surg. 2015 Sep;75(3):275-80. doi: 10.1097/SAP.0000000000000109.
Butz DR, Shenaq DS, Rundell VL, Kepler B, Liederbach E, Thiel J, Pesce C, Murphy GS, Sisco M, Howard MA. Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2015 Jun 5;3(5):e391. doi: 10.1097/GOX.0000000000000355. eCollection 2015 May.
Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.
Shekhawat L, Busheri L, Dixit S, Patel C, Dhar U, Koppiker C. Patient-Reported Outcomes Following Breast Reconstruction Surgery and Therapeutic Mammoplasty: Prospective Evaluation 1 Year Post-Surgery with BREAST-Q Questionnaire. Indian J Surg Oncol. 2015 Dec;6(4):356-62. doi: 10.1007/s13193-015-0432-x. Epub 2015 Jul 23.
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Lee MJ, Daniels SL, Wild JRL, Wilson TR; SYSuRG RAGeS Group. Readmissions after general surgery: a prospective multicenter audit. J Surg Res. 2017 Mar;209:53-59. doi: 10.1016/j.jss.2016.09.020. Epub 2016 Sep 19.
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Strang P. Cancer pain--a provoker of emotional, social and existential distress. Acta Oncol. 1998;37(7-8):641-4. doi: 10.1080/028418698429973.
Zielinski T, Lorenc-Podgorska K, Antoszewski B. Why women who have mastectomy decide not to have breast reconstruction? Pol Przegl Chir. 2015 Feb 3;86(10):451-5. doi: 10.2478/pjs-2014-0081.
American Society of Plastic Surgeons. (2015). Plastic surgery statistics report. Retrived from https://d2wirczt3b6wjm.cloudfront.net/News/Statistics/2015/plastic-surgery-statistics-full-report-2015.pdf
Gassman AA, Yoon AP, Festekjian J, Da Lio AL, Tseng CY, Crisera C. Comparison of immediate postoperative pain in implant-based breast reconstructions. J Plast Reconstr Aesthet Surg. 2016 May;69(5):604-16. doi: 10.1016/j.bjps.2015.12.009. Epub 2016 Jan 7.
Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
Viscusi ER, Sinatra R, Onel E, Ramamoorthy SL. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. 2014 Feb;30(2):102-10. doi: 10.1097/AJP.0b013e318288e1f6.
Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.
Fayezizadeh M, Majumder A, Neupane R, Elliott HL, Novitsky YW. Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction. Am J Surg. 2016 Sep;212(3):399-405. doi: 10.1016/j.amjsurg.2015.12.026. Epub 2016 Apr 12.
Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg. 2008 Jul;122(1):39-52. doi: 10.1097/PRS.0b013e3181774349.
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Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16.
Coopey SB, Specht MC, Warren L, Smith BL, Winograd JM, Fleischmann K. Use of preoperative paravertebral block decreases length of stay in patients undergoing mastectomy plus immediate reconstruction. Ann Surg Oncol. 2013 Apr;20(4):1282-6. doi: 10.1245/s10434-012-2678-7. Epub 2012 Oct 14.
Andersen KG, Christensen KB, Kehlet H, Bidstup PE. The Effect of Pain on Physical Functioning After Breast Cancer Treatment: Development and Validation of an Assessment Tool. Clin J Pain. 2015 Sep;31(9):794-802. doi: 10.1097/AJP.0000000000000156.
Campbell I, Cavanagh S, Creighton J, French R, Banerjee S, Kerr E, Shirley R. To infiltrate or not? Acute effects of local anaesthetic in breast surgery. ANZ J Surg. 2015 May;85(5):353-7. doi: 10.1111/ans.12541. Epub 2014 Apr 22.
Byager N, Hansen MS, Mathiesen O, Dahl JB. The analgesic effect of wound infiltration with local anaesthetics after breast surgery: a qualitative systematic review. Acta Anaesthesiol Scand. 2014 Apr;58(4):402-10. doi: 10.1111/aas.12287.
Zielinski J, Jaworski R, Smietanska I, Irga N, Wujtewicz M, Jaskiewicz J. A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast. Med Sci Monit. 2011 Oct;17(10):CR589-97. doi: 10.12659/msm.881986.
Tam KW, Chen SY, Huang TW, Lin CC, Su CM, Li CL, Ho YS, Wang WY, Wu CH. Effect of wound infiltration with ropivacaine or bupivacaine analgesia in breast cancer surgery: A meta-analysis of randomized controlled trials. Int J Surg. 2015 Oct;22:79-85. doi: 10.1016/j.ijsu.2015.07.715. Epub 2015 Aug 12.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00045562
Identifier Type: -
Identifier Source: org_study_id
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