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Levobupivacaine and Lidocaine for Paravertebral Block Causes Greater Hemodynamic Oscillations Than Levobupivacaine

Primary Purpose

Breast Tumors, Hypotension, Bradycardia

Status
Unknown status
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
levobupivacaine
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA one and two status
  • regular heart rhythm
  • weight between 50 and 95 pounds

Exclusion Criteria:

  • patient refusal
  • coagulation disorder
  • allergy to local anesthetics
  • arrhythmias with or without valvular disease
  • hypertension
  • weight less than 50 pounds or more than 95 pounds

Sites / Locations

  • University Hospital Dubrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

0,5% levobupivacaine with 2% lidocaine

0,5% levobupivacine

Arm Description

7,0 ml.of mixture 0,5% levobupivacaine with 2% lidocaine are given per level Th2,Th3,Th4 for ultrasound guided paravertebral blocks in breast surgery

7,0 ml. 0,5% levobupivacaine are given per level Th2,Th3,Th4, given for ultrasound guided paravertebral blocks in breast surgery

Outcomes

Primary Outcome Measures

Stroke Volume Variation(SVV)within and between groups of patients
Determine which solution of local anesthetic with paravertebral block has a the most favorable effect with regard to the analgesic and hemodynamic effects. Stroke Volume Variation(SVV)will be expressed in percentage change.

Secondary Outcome Measures

postoperative analgesic consumption
Achieve satisfactory postoperative analgesia and thereby faster patient mobilization

Full Information

First Posted
November 6, 2013
Last Updated
May 17, 2022
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT02004834
Brief Title
Levobupivacaine and Lidocaine for Paravertebral Block Causes Greater Hemodynamic Oscillations Than Levobupivacaine
Official Title
A Combination of Levobupivacaine and Lidocaine for Paravertebral Block in Breast Cancer Patients Undergoing Quadrantectomy Causes Greater Hemodynamic Oscillations Than Levobupivacaine Alone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose and the goal of this paper is to show whether the application of a combination of two local anesthetics, as opposed to the application of one local anesthetic at paravertebral block changes the hemodynamic variable. It is therefore a prospective randomized double- blind study, where we do a clinical trial in patients ASA(American Society of Anesthesiologists) 1 and 2 statuses between 18 and 80 years of age, using the ultrasound in plane technology.Upon arrival of patients in the unit for preparation procedures for anesthesia we set the ECG(electrocardiograph), noninvasive blood pressure, oxygen saturation, and arterial cannula in the radial artery After sterile washing of the dorsal surface, paravertebral space was identified with ultrasound using 8 Hz(hertz) linear transducer probe then needle position was confirmed with neurostimulation at the level of 2.0 - 5.0 mA(milliampere). When muscle contraction persisted at 0.4mA(milliampere), the anesthetic was applied in levels of Th 2, Th3, and Th 4 (7,0 milliliters per level). We applied the 0.5 % levobupivacaine and 2 % lidocaine, 7,0 milliliters of mixture per level in one group, while only 0.5 % levobupivacaine also 7,0 milliliters. by level in the second one. After that, the invasive hemodynamic monitoring was placed on patients and the induction with 1 % propofol 2-2.5 mg/kg.and Vecuronium 0,08 mg/kg. was performed with the application of supraglottic airway gel of appropriate size. The maintenance of anesthesia and sedation will be conducted with Propofol 1 % continuously ( 25-150 mcg / kg / min.)The measurements will be taken every 5 minutes during the first hour of the application of paravertebral block, then every 15 minutes during the second hour and if the operation takes more than two hours, the measurements are performed every 30 minutes. Postoperatively, invasive hemodynamic monitoring will be removed in post-anesthesia recovery room together with the arterial cannula and the patient will be sent to the hospital ward with non-invasive hemodynamic monitoring (blood pressure, pulse, saturation) until the termination of the blocks.Statistical methods, By comparing two target groups, we analysed the strength of the test with following assumptions: X2 difference test, the expected difference in variances in stroke volume between groups of 60%, α significance level of 0.05, and the minimum statistical test strength of 85%. The required total sample should include at least 80 patients, that is, 40 per group.Data will be presented in tables and graphs. Descriptive statistics of examined variables with appropriate measures of central tendency will be made. Smirnov -Kolmogorov test will assess the normality of data distribution. According to the received results, the appropriate parametric and / or nonparametric tests will be used. Comparisons of quantitative values between the two groups will be analyzed using the independent t-test or Mann-Whitney U test. Dependent values within each group will be analyzed using analysis of variance for repeated measures or Friedman test. Differences in categorical values will be analyzed by X2 test. The appropriate regression model will be made in order to predict the variability of stroke volume in which the dependent variable will be a variation of the stroke volume, while relevant clinical values will be taken as predictor variables. All P values smaller than 0.05 will be considered significant. This research is to present the main results - the existence of the significant change in Stroke Volume Variation (SVV) between groups using invasive hemodynamic monitoring, the changes of Stroke Volume Variation(SVV) depending on the time from the application within groups, differences in volume compensation of crystalloids and colloids and the need for the application of vasoactive drugs. Furthermore, as a secondary results we will present the time to maximal block development, the duration of post operative analgesia, patient satisfaction and time needed for the full recovery from the block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Tumors, Hypotension, Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0,5% levobupivacaine with 2% lidocaine
Arm Type
Active Comparator
Arm Description
7,0 ml.of mixture 0,5% levobupivacaine with 2% lidocaine are given per level Th2,Th3,Th4 for ultrasound guided paravertebral blocks in breast surgery
Arm Title
0,5% levobupivacine
Arm Type
Active Comparator
Arm Description
7,0 ml. 0,5% levobupivacaine are given per level Th2,Th3,Th4, given for ultrasound guided paravertebral blocks in breast surgery
Intervention Type
Drug
Intervention Name(s)
levobupivacaine
Other Intervention Name(s)
chirocaine
Intervention Description
Comparing: 0,5% levobupivacaine with 2% lidocaine
Primary Outcome Measure Information:
Title
Stroke Volume Variation(SVV)within and between groups of patients
Description
Determine which solution of local anesthetic with paravertebral block has a the most favorable effect with regard to the analgesic and hemodynamic effects. Stroke Volume Variation(SVV)will be expressed in percentage change.
Time Frame
12 hours perioperative
Secondary Outcome Measure Information:
Title
postoperative analgesic consumption
Description
Achieve satisfactory postoperative analgesia and thereby faster patient mobilization
Time Frame
12 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA one and two status regular heart rhythm weight between 50 and 95 pounds Exclusion Criteria: patient refusal coagulation disorder allergy to local anesthetics arrhythmias with or without valvular disease hypertension weight less than 50 pounds or more than 95 pounds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ino Husedzinovic, PhD,MD
Organizational Affiliation
Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11152029
Citation
Saito T, Den S, Cheema SP, Tanuma K, Carney E, Carlsson C, Richardson J. A single-injection, multi-segmental paravertebral block-extension of somatosensory and sympathetic block in volunteers. Acta Anaesthesiol Scand. 2001 Jan;45(1):30-3. doi: 10.1034/j.1399-6576.2001.450105.x.
Results Reference
background
PubMed Identifier
17715684
Citation
Hara K, Sakura S, Nomura T. [Use of ultrasound for thoracic paravertebral block]. Masui. 2007 Aug;56(8):925-31. Japanese.
Results Reference
background
PubMed Identifier
18155058
Citation
Garutti I, Olmedilla L, Cruz P, Pineiro P, De la Gala F, Cirujano A. Comparison of the hemodynamic effects of a single 5 mg/kg dose of lidocaine with or without epinephrine for thoracic paravertebral block. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):57-63. doi: 10.1016/j.rapm.2007.07.009.
Results Reference
background
PubMed Identifier
19923509
Citation
Kungys G, Rose DD, Fleming NW. Stroke volume variation during acute normovolemic hemodilution. Anesth Analg. 2009 Dec;109(6):1823-30. doi: 10.1213/ANE.0b013e3181ba41af.
Results Reference
background
PubMed Identifier
20623210
Citation
Alhashemi JA, Cecconi M, della Rocca G, Cannesson M, Hofer CK. Minimally invasive monitoring of cardiac output in the cardiac surgery intensive care unit. Curr Heart Fail Rep. 2010 Sep;7(3):116-24. doi: 10.1007/s11897-010-0019-3.
Results Reference
background
PubMed Identifier
20947592
Citation
Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14. Erratum In: Br J Anaesth. 2013 Sep;111(3):522.
Results Reference
background
PubMed Identifier
21804697
Citation
Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
Results Reference
result
PubMed Identifier
21486711
Citation
Tahiri Y, Tran DQ, Bouteaud J, Xu L, Lalonde D, Luc M, Nikolis A. General anaesthesia versus thoracic paravertebral block for breast surgery: a meta-analysis. J Plast Reconstr Aesthet Surg. 2011 Oct;64(10):1261-9. doi: 10.1016/j.bjps.2011.03.025. Epub 2011 Apr 12.
Results Reference
result

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Levobupivacaine and Lidocaine for Paravertebral Block Causes Greater Hemodynamic Oscillations Than Levobupivacaine

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