Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction
NCT ID: NCT02274077
Last Updated: 2016-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-01-31
2017-06-30
Brief Summary
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1. Length of Stay (LOS)
2. Return of bowel function
3. Narcotic pain medication requirements
4. Nausea and emesis
5. Pain scores
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Detailed Description
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Patients will be randomly separated into 2 groups at the time of surgery through the randomization log of the investigational drug service (IDS) pharmacy. At the request of the attending surgeon a solution will be prepared and delivered to the operating room in a blinded fashion concealed within a shielded vial.
During the abdominal component separation, dissection of the tissue planes housing the sensory fibers will be exposed to allow insertion of a large spinal needle under direct visualization on each side of the abdominal wall. Depending on the study group, the attending surgeon will inject an unknown solution (solution A or B) of either 30ml of Exparel ((bupivacaine liposome injectable suspension) 1.3% ( 13.3mg/ml)). The final test solution will be prepared in the IDS pharmacy by adding a 20 mL Exparel vial and 40cc of normal saline for a total of 60cc with a bupivacaine concentration of 0.44%. This will then be split into two 30cc solutions to be injected into each side of the transverse abdominal plane. A patient in the placebo group will be injected with 30cc of Normal Saline into the TAP region on each side of the abdomen.
All patients, independent of their study group will be provided with Patient Controlled Analgesics (PCA) using Hydromorphone or orally dosed narcotic/acetaminophen combo analgesics to ensure adequate post-operative pain control. The pain scores, dermatomal level of anesthesia, nausea, emesis, return of bowel function and length of stay will be logged into the electronic medical record. Once data collection is complete the groups will be revealed and all of the data will undergo statistical analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EXPAREL
Bilateral, one time injections using 30ml of EXPAREL ((bupivacaine liposome injectable suspension) 1.3% ( 13.3mg/ml)) into the transverse abdominal plane at the time of abdominal component separation. A total of 60cc used with a Bupivacaine concentration of 0.44%.
EXPAREL
Normal Saline
Bilateral, one time injections of 30ml normal saline into the transverse abdominal plane at the time of abdominal component separation.
Normal Saline
Interventions
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EXPAREL
Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients younger than 18 years of age will be excluded.
* Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver.
* Patients' with hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations and will therefore be excluded from the study.
18 Years
ALL
Yes
Sponsors
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Chester Mays
OTHER
Responsible Party
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Chester Mays
Chief Resident
Principal Investigators
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Howard N Langstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Division of Plastic and Reconstructive Surgery
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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References
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Girotto JA, Chiaramonte M, Menon NG, Singh N, Silverman R, Tufaro AP, Nahabedian M, Goldberg NH, Manson PN. Recalcitrant abdominal wall hernias: long-term superiority of autologous tissue repair. Plast Reconstr Surg. 2003 Jul;112(1):106-14. doi: 10.1097/01.PRS.0000066162.18720.C8.
Shestak KC, Edington HJ, Johnson RR. The separation of anatomic components technique for the reconstruction of massive midline abdominal wall defects: anatomy, surgical technique, applications, and limitations revisited. Plast Reconstr Surg. 2000 Feb;105(2):731-8; quiz 739. doi: 10.1097/00006534-200002000-00041.
Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023.
Ewart CJ, Lankford AB, Gamboa MG. Successful closure of abdominal wall hernias using the components separation technique. Ann Plast Surg. 2003 Mar;50(3):269-73; discussion 273-4. doi: 10.1097/01.sap.0000046911.07345.0d.
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.
Kampe S, Warm M, Kasper SM, Diefenbach C. Concept for postoperative analgesia after pedicled TRAM flaps: continuous wound instillation with 0.2% ropivacaine via multilumen catheters. A report of two cases. Br J Plast Surg. 2003 Jul;56(5):478-83. doi: 10.1016/s0007-1226(03)00180-2.
Hivelin M, Wyniecki A, Plaud B, Marty J, Lantieri L. Ultrasound-guided bilateral transversus abdominis plane block for postoperative analgesia after breast reconstruction by DIEP flap. Plast Reconstr Surg. 2011 Jul;128(1):44-55. doi: 10.1097/PRS.0b013e3182174090.
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.
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
Other Identifiers
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RSRB00042032
Identifier Type: -
Identifier Source: org_study_id
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