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Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial

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 remai...

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Autores principales: Zhong, Toni, Ojha, Marie, Bagher, Shaghayegh, Butler, Kate, O’Neill, Anne C, McCluskey, Stuart A, Clarke, Hance, Hofer, Stefan OP, Srinivas, Coimbatore
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3878890/
https://www.ncbi.nlm.nih.gov/pubmed/24325953
http://dx.doi.org/10.1186/1745-6215-14-424
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author Zhong, Toni
Ojha, Marie
Bagher, Shaghayegh
Butler, Kate
O’Neill, Anne C
McCluskey, Stuart A
Clarke, Hance
Hofer, Stefan OP
Srinivas, Coimbatore
author_facet Zhong, Toni
Ojha, Marie
Bagher, Shaghayegh
Butler, Kate
O’Neill, Anne C
McCluskey, Stuart A
Clarke, Hance
Hofer, Stefan OP
Srinivas, Coimbatore
author_sort Zhong, Toni
collection PubMed
description 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01398982
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spelling pubmed-38788902014-01-03 Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial Zhong, Toni Ojha, Marie Bagher, Shaghayegh Butler, Kate O’Neill, Anne C McCluskey, Stuart A Clarke, Hance Hofer, Stefan OP Srinivas, Coimbatore Trials Study Protocol 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01398982 BioMed Central 2013-12-10 /pmc/articles/PMC3878890/ /pubmed/24325953 http://dx.doi.org/10.1186/1745-6215-14-424 Text en Copyright © 2013 Zhong et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Zhong, Toni
Ojha, Marie
Bagher, Shaghayegh
Butler, Kate
O’Neill, Anne C
McCluskey, Stuart A
Clarke, Hance
Hofer, Stefan OP
Srinivas, Coimbatore
Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title_full Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title_fullStr Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title_full_unstemmed Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title_short Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
title_sort transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3878890/
https://www.ncbi.nlm.nih.gov/pubmed/24325953
http://dx.doi.org/10.1186/1745-6215-14-424
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