NCT01185457

Brief Summary

The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

August 18, 2010

Last Update Submit

October 26, 2012

Conditions

Shoulder SurgeryBeach Chair PositionInterscalene BlockHRVAutonomic Nervous System

Keywords

Shoulder surgeryBeach chair positionInterscalene blockHRVAutonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • Effect of interscalene block on Heart Rate Variability (HRV)

    The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.

    1 year

Secondary Outcomes (2)

  • Interscalene block and beach chair positioning

    2 years

  • Interscalene block and beach chair positioning

    2 years

Study Arms (2)

Left interscalene block

Left shoulder surgery under left interscalene block and HRV

Right interscalene block

Right shoulder surgery under right interscalene block and HRV

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients for elective shoulder surgery

You may qualify if:

  • elective shoulder surgery
  • Age 20- 45 years old
  • ASA I - II

You may not qualify if:

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurologic deficit in the arm that is going to be operated
  • Allergy to local anesthetics
  • BMI \> 35
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication
  • Arrythmia
  • Ischaemic heart disease
  • Diabetes mellitus
  • Thyroid function disorders
  • Patients with conduction disorders on the ECG
  • Electrolyte disorders (K+, Na+, Ca++)
  • Patients on medication that affect the ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larissa University Hospital

Larissa, Thessaly, 41110, Greece

Location

Related Publications (7)

  • Pomeranz B, Macaulay RJ, Caudill MA, Kutz I, Adam D, Gordon D, Kilborn KM, Barger AC, Shannon DC, Cohen RJ, et al. Assessment of autonomic function in humans by heart rate spectral analysis. Am J Physiol. 1985 Jan;248(1 Pt 2):H151-3. doi: 10.1152/ajpheart.1985.248.1.H151.

    PMID: 3970172BACKGROUND

  • Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

    PMID: 2874900BACKGROUND

  • Muzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993

    BACKGROUND

  • Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. doi: 10.1161/01.cir.84.2.482.

    PMID: 1860193BACKGROUND

  • RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. doi: 10.1161/01.res.4.4.470. No abstract available.

    PMID: 13330193BACKGROUND

  • Rogers MC, Battit G, McPeek B, Todd D. Lateralization of sympathetic control of the human sinus node: ECG changes of stellate ganglion block. Anesthesiology. 1978 Feb;48(2):139-41. doi: 10.1097/00000542-197802000-00009. No abstract available.

    PMID: 655444BACKGROUND

  • Schwartz PJ, Locati EH, Moss AJ, Crampton RS, Trazzi R, Ruberti U. Left cardiac sympathetic denervation in the therapy of congenital long QT syndrome. A worldwide report. Circulation. 1991 Aug;84(2):503-11. doi: 10.1161/01.cir.84.2.503.

    PMID: 1860195BACKGROUND

Study Officials

  • Eleni Chantzi, Medicine

    Larissa University Hospital

    PRINCIPAL INVESTIGATOR

  • George Vretzakis, Medicine

    Larissa University Hospital

    STUDY DIRECTOR

  • Metaxia Bareka, Medicine

    Larissa University Hospital

    STUDY CHAIR

  • Christos Iatrou, Medicine

    Alexandroupoli University Hospital

    STUDY CHAIR

  • Theophilos Karachalios, Medicine

    Larissa University Hospital

    STUDY CHAIR

  • Marina Simaioforidou, Medicine

    Larissa University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 20, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

GR(1)