title: Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block.
  
  
  METHODS
  This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay.
  
  
  CONCLUSIONS
  Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01398982.
authors: Division of Plastic & Reconstructive Surgery, University Health Network, 200 Elizabeth St, Toronto, ON M5G 2C4, Canada. Toni.zhong@uhn.ca.
authors: Toni
authors: T
authors: Zhong
authors: Marie
authors: M
authors: Ojha
authors: Shaghayegh
authors: S
authors: Bagher
authors: Kate
authors: K
authors: Butler
authors: Anne C
authors: AC
authors: O'Neill
authors: Stuart A
authors: SA
authors: McCluskey
authors: Hance
authors: H
authors: Clarke
authors: Stefan O P
authors: SO
authors: Hofer
authors: Coimbatore
authors: C
authors: Srinivas
mesh_terms: D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016462:Mammaplasty; D009407:Nerve Block / Q000379:methods*; D010149:Postoperative Pain / Q000517:prevention & control*; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic; D013524:Surgical Flaps