Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction

NCT02274077 | Withdrawn Phase 4 DMC

• 1 other identifier: RSRB00042032
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal wall reconstruction population using an intraoperative local anesthetic infusion. A prospective randomized double blind study of patients undergoing component separation will be performed in order to assess the following outcomes:

1. 1.Length of Stay (LOS)
2. 2.Return of bowel function
3. 3.Narcotic pain medication requirements
4. 4.Nausea and emesis
5. 5.Pain scores

Conditions

Hernia, Ventral

Keywords

length of stay; nausea; emesis; bowel function; pain scores; narcotic pain medication; post operative period

Outcome Measures

Primary Outcomes (5)

• length of stay

  determine the length of hospital stay after surgery

  participants will be followed for the duration of hospital stay, an expected average of 1 week

• postoperative nausea

  evaluate the presence or absence of postoperative nausea

  participants will be followed for the duration of hospital stay, an expected average of 1 week

• postoperative emesis

  evaluate for the presence or absence of postoperative emesis

  participants will be followed for the duration of hospital stay, an expected average of 1 week

• postoperative return of bowel function

  record when bowel function returns following surgery

  participants will be followed for the duration of hospital stay, an expected average of 1 week

• postoperative pain score

  assess pain score 0-10 a various time points following surgery

  participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes (1)

• adjunct narcotic pain medication use

  participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

EXPAREL

ACTIVE COMPARATOR

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%.

Drug: EXPAREL

Normal Saline

PLACEBO COMPARATOR

Bilateral, one time injections of 30ml normal saline into the transverse abdominal plane at the time of abdominal component separation.

Drug: Normal Saline

Interventions

EXPAREL DRUG

Also known as: bupivacaine liposome injectable suspension

EXPAREL

Normal Saline DRUG

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects to be included are all competent patients, 18 years of age or older, who undergo abdominal component separation for a hernia.

You may not qualify if:

• Patients who are not having abdominal component separation or are receiving another form of regional anesthesia will be excluded.
• 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.

Sponsors & Collaborators

• Chester Mays: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (10)

• 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.

  PMID: 12832883 BACKGROUND

• 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.

  PMID: 10697187 BACKGROUND

• 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.

  PMID: 2143588 BACKGROUND

• 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.

  PMID: 12800903 BACKGROUND

• 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.

  PMID: 18827631 BACKGROUND

• 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.

  PMID: 12890461 BACKGROUND

• 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.

  PMID: 21701318 BACKGROUND

• 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.

  PMID: 22067185 BACKGROUND

• 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.

  PMID: 20175754 RESULT

• 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.

  PMID: 17961838 RESULT

MeSH Terms

Conditions

Hernia, Ventral; Nausea; Vomiting

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Howard N Langstein, MD

  University of Rochester Division of Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Resident

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 24, 2014
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

US (1)