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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722927
Other study ID # IRB00045562
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 14, 2018
Est. completion date January 29, 2020

Study information

Verified date May 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.


Description:

Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date January 29, 2020
Est. primary completion date January 29, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction - 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 an autologous tissue reconstruction. - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (29)

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

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. — View Citation

Bonnet F, Marret E. Influence of anaesthetic and analgesic techniques on outcome after surgery. Br J Anaesth. 2005 Jul;95(1):52-8. Epub 2004 Dec 3. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12. — View Citation

Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Morrison JE Jr, Jacobs VR. Reduction or elimination of postoperative pain medication after mastectomy through use of a temporarily placed local anesthetic pump vs. control group. Zentralbl Gynakol. 2003 Jan;125(1):17-22. — View Citation

Nadeau MH, Saraswat A, Vasko A, Elliott JO, Vasko SD. Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Aesthet Surg J. 2016 Feb;36(2):NP47-52. doi: 10.1093/asj/sjv149. Epub 2015 Dec 23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Strang P. Cancer pain--a provoker of emotional, social and existential distress. Acta Oncol. 1998;37(7-8):641-4. Review. — View Citation

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. Review. — View Citation

US Food and Drug Administration. FDA Label Approved on 10/28/2011 for Exparel. US Silver Spring, MD: US Food and Drug Administration. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf

US Food and Drug Administration. Marcaine Bupivcacaine HCl Injection Label. US Silver Spring, MD: US Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf

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. — View Citation

Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. — View Citation

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. — View Citation

Zielinski T, Lorenc-Podgórska 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. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Visual Analog Scores This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes. 48 hours
Secondary Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty) This will be measured during first 48 hours postoperatively 48 hours
Secondary Number of Morphine Doses Across All Subjects This will be measured by the number of doses within the first month postoperatively and recorded on pain medication daily diary kept by subject. 1 Month
Secondary Length of Stay for Hospitalization The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded. up to 47 Hours
Secondary Readmission Rates to the Hospital Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded Month 2
Secondary Frequency of Postoperative Opioid Related Adverse Effects Frequency of postoperative opioid related adverse effects within the first week of surgery will be recorded. This includes nausea, vomiting, pruritus, allergy, respiratory depression. Postoperatively, 1 week
Secondary Pain Intensity With Movement This will be measured by using the Pain Assessment Questionnaire. Total scores are 0-50 with higher scores denoting worse outcomes. Up to 2 months