A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy
NCT ID: NCT03540537
Last Updated: 2018-10-23
Study Results
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Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2018-05-09
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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PCA for Open Hepatectomy
Patient-controlled intravenous analgesia in Open hepatectomy (PCA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
QLB for Open Hepatectomy
Bilateral quadratus lumborum block with 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Quadratus Lumborum Block
Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
TPVB for Open hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Thoracic Paravertebral Block
Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.
PCA for Laparoscopic Hepatectomy
Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
QLB for Laparoscopic Hepatectomy
Bilateral quadratus lumborum block 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Quadratus Lumborum Block
Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
TPVB for Laparoscopic Hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Thoracic Paravertebral Block
Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.
Interventions
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Patient-controlled intravenous analgesia
PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
Quadratus Lumborum Block
Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
Thoracic Paravertebral Block
Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) risk class I-III;
* Body Mass Index (BMI) is not lesser than 18 and not greater than 30;
Exclusion Criteria
* Allergy to the any agents used in current clinical trial;
* Dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs;
* Patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.);
* Previous abdominal surgery (except for diagnostic biopsy);
* New York Heart Association (NYHA) classification of cardiac function grade IV and/or Ejection Fraction (EF)≤55%;
* Child-Pugh grading
* Liver function of grade C (Child-Pugh grading)
* Glomerular filtration rate≤60ml/min/1.73m2;
* Obstructive sleep apnea syndrome;
* Chronic obstructive pulmonary disease, asthma, active tuberculosis;
* Cardiac rhythm disorders;
* Past or present history of nervous system diseases and mental disorders (such as epilepsy, Alzheimer's disease, Parkinsonism syndrome, depression,etc.);
* Autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.)
* Malignant tumors of other systems;
* Other operations are required during the same period;
18 Years
65 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Tao Tao, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NFEC-2017-190
Identifier Type: -
Identifier Source: org_study_id
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