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      Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial

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          Abstract

          Background

          The current standard for pain control following liver surgery is intravenous, patient-controlled analgesia (IV PCA) or epidural analgesia. We have developed a modification of a regional technique called medial open transversus abdominis plane (MOTAP) catheter analgesia. The MOTAP technique involves surgically placed catheters through the open surgical site into a plane between the internal oblique muscle and the transverse abdominis muscle superiorly. The objective of this trial is to assess the efficacy of this technique.

          Methods/design

          This protocol describes a multicentre, prospective, blinded, randomized controlled trial. One hundred and twenty patients scheduled for open liver resection through a subcostal incision will be enrolled. All patients will have two MOTAP catheters placed at the conclusion of surgery. Patients will be randomized to one of two parallel groups: experimental (local anaesthetic through MOTAP catheters) or placebo (normal saline through MOTAP catheters). Both groups will also receive IV PCA. The primary endpoint is mean cumulative postoperative opioid consumption over the first 2 postoperative days (48 hours). Secondary outcomes include pain intensity, patient functional outcomes, and the incidence of complications.

          Discussion

          This trial has been approved by the ethics boards at participating centres and is currently enrolling patients. Data collection will be completed by the end of 2014 with analysis mid-2015 and publication by the end of 2015.

          Trial registration

          The study is registered with http://clinicaltrials.gov ( NCT01960049; 23 September 2013)

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          Most cited references27

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          Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database.

          To assess the trends in perioperative outcome of hepatectomy for hepatobiliary diseases. Data of 1222 consecutive patients who underwent hepatectomy for hepatobiliary diseases from July 1989 to June 2003 in a tertiary institution were collected prospectively. Perioperative outcome of patients in the first (group I) and second (group II) halves of this period was compared. Factors associated with morbidity and mortality were analyzed. Diagnoses included hepatocellular carcinoma (n = 734), other liver cancers (n = 257), extrahepatic biliary malignancies (n = 43), hepatolithiasis (n = 101), benign liver tumors (n = 61), and other diseases (n = 26). The majority of patients (61.8%) underwent major hepatectomy of > or = 3 segments. The overall hospital mortality and morbidity were 4.9% and 32.4%, respectively. The number of hepatectomies increased from 402 in group I to 820 in group II, partly as a result of more liberal patient selection. Group II had more elderly patients (P = 0.006), more patients with comorbid illnesses (P = 0.001), and significantly worse liver function. Nonetheless, group II had lower blood loss (median 750 versus 1450 mL, P < 0.001), perioperative transfusion (17.3% versus 67.7%, P < 0.001), morbidity (30.0% versus 37.3%, P = 0.012), and hospital mortality (3.7% versus 7.5%, P = 0.004). On multivariate analysis, hypoalbuminemia, thrombocytopenia, elevated serum creatinine, major hepatic resection, and transfusion were the significant predictors of hospital mortality, whereas concomitant extrahepatic procedure, thrombocytopenia, and transfusion were the predictors of morbidity. Perioperative outcome has improved despite extending the indication of hepatectomy to more high-risk patients. The role of hepatectomy in the management of hepatobiliary diseases can be expanded. Reduced perioperative transfusion is the main contributory factor for improved outcome.
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            Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall.

            Previous descriptions of the thoracolumbar spinal nerves innervating the anterior abdominal wall have been inconsistent. With modern surgical and anesthetic techniques that involve or may damage these nerves, an improved understanding of the precise course and variability of this anatomy has become increasingly important. The course of the nerves of the anterior abdominal is described based on a thorough cadaveric study and review of the literature. Twenty human cadaveric hemi-abdominal walls were dissected to map the course of the nerves of the anterior abdominal wall. Dissection included a comprehensive tracing of nerves and their branches from their origins in five specimens. The branching pattern and course of all nerves identified were described. All thoracolumbar nerves that innervate the anterior abdominal wall were found to travel as multiple mixed segmental nerves, which branch and communicate widely within the transversus abdominis plane (TAP). This communication may occur at multiple locations, including large branch communications anterolaterally (intercostal plexus), and in plexuses that run with the deep circumflex iliac artery (DCIA) (TAP plexus) and the deep inferior epigastric artery (DIEA) (rectus sheath plexus). Rectus abdominis muscle is innervated by segments T6-L1, with a constant branch from L1. The umbilicus is always innervated by a branch of T10. As such, identification or damage to individual nerves in the TAP or within rectus sheath is unlikely to involve single segmental nerves. An understanding of this anatomy may contribute to explaining clinical outcomes and preventing complications, following TAP blocks for anesthesia and DIEA perforator flaps for breast reconstruction. (c) 2008 Wiley-Liss, Inc.
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              Prospective evaluation of Pringle maneuver in hepatectomy for liver tumors by a randomized study.

              To evaluate whether vascular inflow occlusion by the Pringle maneuver during hepatectomy can be safe and effective in reducing blood loss. Hepatectomy can be performed with a low mortality rate, but massive hemorrhage during surgery remains a potentially lethal problem. The Pringle maneuver is traditionally used during hepatectomy to reduce blood loss, but there is a potential harmful effect on the metabolic function of hepatocytes. There has been no prospective randomized study to determine whether the Pringle maneuver can decrease blood loss during hepatectomy, improve outcome, or affect the metabolism of hepatocytes. From July 1995 to February 1997, we studied 100 consecutive patients who underwent hepatectomy for liver tumors. The patients were randomly assigned to liver transection under intermittent Pringle maneuver of 20 minutes and a 5-minute clamp-free interval (n = 50), or liver transection without the Pringle maneuver (n = 50). The surface area of liver transection was measured and blood loss during transection per square centimeter of transection area was calculated. Routine liver biochemistry, arterial ketone body ratio (AKBR), and the indocyanine green (ICG) clearance test were done. The two groups were comparable in terms of preoperative liver function and in the proportion of patients having major hepatectomy. The Pringle maneuver resulted in less blood loss per square centimeter of transection area (12 mL/cm2 vs. 22 mL/cm2, p = 0.0001), a shorter transection time per square centimeter of transection area (2 min/cm2 vs. 2.8 min/cm2, p = 0.016), a significantly higher AKBR in the first 2 hours after hepatectomy, lower serum bilirubin levels in the early postoperative period, and, in cirrhotic patients, higher serum transferrin levels on postoperative days 1 and 8. The complication rate, the hospital mortality rate, and the ICG retention at 15 minutes on postoperative day 8 were equal for the two groups. Performing the Pringle maneuver during liver transection resulted in less blood loss and better preservation of liver function in the early postoperative period. This is probably because there was less hemodynamic disturbance induced by the bleeding.
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                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2014
                21 June 2014
                : 15
                : 241
                Affiliations
                [1 ]Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, Canada
                [2 ]Department of Surgery, University of Toronto, Toronto, Canada
                [3 ]Department of Surgery, University Health Network, Toronto, Canada
                [4 ]Department of Anaesthesia, Sunnybrook Health Sciences Centre, Toronto, Canada
                [5 ]Department of Anaesthesia, University of Toronto, Toronto, Canada
                [6 ]Department of Anaesthesia and Pain Management, University Health Network, Toronto, Canada
                [7 ]Clinical Epidemiology Unit, Sunnybrook Research Institute, Toronto, Canada
                Article
                1745-6215-15-241
                10.1186/1745-6215-15-241
                4078361
                24950773
                d16acced-09b9-4a98-a95b-85f5e78e1a26
                Copyright © 2014 Karanicolas et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 23 April 2014
                : 5 June 2014
                Categories
                Study Protocol

                Medicine
                liver surgery,analgesia,transversus abdominis plane,randomized controlled trial
                Medicine
                liver surgery, analgesia, transversus abdominis plane, randomized controlled trial

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