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Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

Primary Purpose

Brachial Plexus Anesthesia, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
supraclavicular brachial plexus block
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brachial Plexus Anesthesia focused on measuring analgesia, regional anesthesia, surgery, duration of analgesia, dexamethasone added to levobupivacaine compared to levobupivacaine alone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged 18 years or older
  • ASA (American Society of Anesthesiologists) physical status I, II or III

Exclusion Criteria:

  • refusal of the patients to give informed consent
  • preexisting coagulation disorders
  • local infection at the site of the block
  • neuropathy
  • drug or alcohol abusers
  • known allergy to the drug used in study
  • operation time exceeding six hours

Sites / Locations

  • Clinical Hospital Dubrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexamethasone with levobupivacaine

levobupivacaine

Arm Description

25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery

25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery

Outcomes

Primary Outcome Measures

duration of analgesia
Duration of analgesia after supraclavicular block

Secondary Outcome Measures

postoperative analgesic consumption

Full Information

First Posted
November 25, 2012
Last Updated
July 28, 2015
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT01739270
Brief Title
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia
Official Title
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

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
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.
Detailed Description
Operations of upper extremities are often performed in regional anesthesia blocks. Single-injection blocks are effective, but time limited. Adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. This effect will result in less opioid use postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Plexus Anesthesia, Analgesia
Keywords
analgesia, regional anesthesia, surgery, duration of analgesia, dexamethasone added to levobupivacaine compared to levobupivacaine alone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone with levobupivacaine
Arm Type
Active Comparator
Arm Description
25ml 0.5% levobupivacaine plus 4mg Dexamethasone are given for supraclavicular brachial plexus block for upper extremity surgery
Arm Title
levobupivacaine
Arm Type
Active Comparator
Arm Description
25ml 0.5% levobupivacaine plus 1ml 0.9% saline are given for supraclavicular brachial plexus block for upper extremity surgery
Intervention Type
Procedure
Intervention Name(s)
supraclavicular brachial plexus block
Primary Outcome Measure Information:
Title
duration of analgesia
Description
Duration of analgesia after supraclavicular block
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
postoperative analgesic consumption
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 18 years or older ASA (American Society of Anesthesiologists) physical status I, II or III Exclusion Criteria: refusal of the patients to give informed consent preexisting coagulation disorders local infection at the site of the block neuropathy drug or alcohol abusers known allergy to the drug used in study operation time exceeding six hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ino Husedzinovic, Professor
Organizational Affiliation
Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20814282
Citation
Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9.
Results Reference
result
PubMed Identifier
20009936
Citation
Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
Results Reference
result
PubMed Identifier
22379567
Citation
Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
Results Reference
result

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Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

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