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Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial

BACKGROUND: Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that an...

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Autores principales: Yuan, Qing, Cui, Xulei, Fei, Yuda, Xu, Zhonghuang, Huang, Yuguang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528343/
https://www.ncbi.nlm.nih.gov/pubmed/31109368
http://dx.doi.org/10.1186/s13063-019-3359-7
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author Yuan, Qing
Cui, Xulei
Fei, Yuda
Xu, Zhonghuang
Huang, Yuguang
author_facet Yuan, Qing
Cui, Xulei
Fei, Yuda
Xu, Zhonghuang
Huang, Yuguang
author_sort Yuan, Qing
collection PubMed
description BACKGROUND: Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that anesthetics spread into the thoracic paravertebral space to exert an analgesic effect. Therefore, we designed this study to compare TMQLB with thoracic paravertebral block (TPVB) in laparoscopic renal surgery in the hope of providing clinical evidence on the analgesic mechanism of TMQLB and its application in laparoscopic renal surgery. METHODS: This trial is a prospective, randomized, single-center, open-label, parallel, three-arm, non-inferiority trial. We intend to include 120 participants undergoing laparoscopic nephrectomy and before surgery they will be randomized into three groups for postoperative pain control: TMQLB experimental group 1 (0.4 ml/kg body weight 0.5% ropivacaine), TMQLB experimental group 2 (0.6 ml/kg body weight 0.5% ropivacaine) or TPVB control group (0.4 ml/kg body weight 0.5% ropivacaine at vertebra T10). Patients will be excluded if they have allergy to anesthetics, infection at the injection site, are on coagulopathy or anticoagulants, on analgesics for chronic illness, have history of substance abuse or have a barrier to communication. Morphine is given in boluses of 1.5~2 mg by intravenous patient-controlled analgesia (IPCA) in the first 48 h after surgery. The primary outcome is the difference between TMQLB group 1 and the TPVB group in the mean visual analogue scale (VAS) pain score in the first 24 h after surgery. Secondary outcomes are the difference between TMQLB group 2 and the TPVB group in the mean VAS score in the first 24 h after surgery, cumulative morphine consumption, long-term pain control, dermatomal distribution of sensory loss, nausea score, pruritus score, ambulation time, time till recovery of bowel movement, quality of recovery, postoperative length of hospital stay and patient satisfaction with anesthesia. Safety data on procedure-related complications will also be summarized. DISCUSSION: This will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03414281. Registered on 9 January 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3359-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-65283432019-05-28 Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial Yuan, Qing Cui, Xulei Fei, Yuda Xu, Zhonghuang Huang, Yuguang Trials Study Protocol BACKGROUND: Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that anesthetics spread into the thoracic paravertebral space to exert an analgesic effect. Therefore, we designed this study to compare TMQLB with thoracic paravertebral block (TPVB) in laparoscopic renal surgery in the hope of providing clinical evidence on the analgesic mechanism of TMQLB and its application in laparoscopic renal surgery. METHODS: This trial is a prospective, randomized, single-center, open-label, parallel, three-arm, non-inferiority trial. We intend to include 120 participants undergoing laparoscopic nephrectomy and before surgery they will be randomized into three groups for postoperative pain control: TMQLB experimental group 1 (0.4 ml/kg body weight 0.5% ropivacaine), TMQLB experimental group 2 (0.6 ml/kg body weight 0.5% ropivacaine) or TPVB control group (0.4 ml/kg body weight 0.5% ropivacaine at vertebra T10). Patients will be excluded if they have allergy to anesthetics, infection at the injection site, are on coagulopathy or anticoagulants, on analgesics for chronic illness, have history of substance abuse or have a barrier to communication. Morphine is given in boluses of 1.5~2 mg by intravenous patient-controlled analgesia (IPCA) in the first 48 h after surgery. The primary outcome is the difference between TMQLB group 1 and the TPVB group in the mean visual analogue scale (VAS) pain score in the first 24 h after surgery. Secondary outcomes are the difference between TMQLB group 2 and the TPVB group in the mean VAS score in the first 24 h after surgery, cumulative morphine consumption, long-term pain control, dermatomal distribution of sensory loss, nausea score, pruritus score, ambulation time, time till recovery of bowel movement, quality of recovery, postoperative length of hospital stay and patient satisfaction with anesthesia. Safety data on procedure-related complications will also be summarized. DISCUSSION: This will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03414281. Registered on 9 January 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3359-7) contains supplementary material, which is available to authorized users. BioMed Central 2019-05-20 /pmc/articles/PMC6528343/ /pubmed/31109368 http://dx.doi.org/10.1186/s13063-019-3359-7 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
spellingShingle Study Protocol
Yuan, Qing
Cui, Xulei
Fei, Yuda
Xu, Zhonghuang
Huang, Yuguang
Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title_full Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title_fullStr Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title_full_unstemmed Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title_short Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
title_sort transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528343/
https://www.ncbi.nlm.nih.gov/pubmed/31109368
http://dx.doi.org/10.1186/s13063-019-3359-7
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