NCT01739270

Brief Summary

Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

November 25, 2012

Last Update Submit

July 28, 2015

Conditions

Keywords

analgesiaregional anesthesiasurgeryduration of analgesiadexamethasone added to levobupivacaine compared to levobupivacaine alone

Outcome Measures

Primary Outcomes (1)

  • duration of analgesia

    Duration of analgesia after supraclavicular block

    24 hour postoperatively

Secondary Outcomes (1)

  • postoperative analgesic consumption

    24 hour

Study Arms (2)

dexamethasone with levobupivacaine

ACTIVE COMPARATOR

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

Procedure: supraclavicular brachial plexus block

levobupivacaine

ACTIVE COMPARATOR

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

Procedure: supraclavicular brachial plexus block

Interventions

dexamethasone with levobupivacainelevobupivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ino Husedzinovic, Professor

    Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology, Resuscitation and Intensive Care Medicine Specialist

Study Record Dates

First Submitted

November 25, 2012

First Posted

December 3, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations