Clinical trial NCT01185457: Effect of Interscalene Block on Heart Rate Variability (HRV)
Official title: Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Surgery
Beach Chair Position
Interscalene Block
HRV
Autonomic Nervous System
Keywords: Shoulder surgery
Beach chair position
Interscalene block
HRV
Autonomic nervous system
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients for elective shoulder surgery

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effect of interscalene block on Heart Rate Variability (HRV)
timeFrame: 1 year
Secondary outcomes:
measure: Interscalene block and beach chair positioning
timeFrame: 2 years
measure: Interscalene block and beach chair positioning
timeFrame: 2 years
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessaly
Study officials:
affiliation: Larissa University Hospital
name: Eleni Chantzi, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Larissa University Hospital
name: George Vretzakis, Medicine
role: STUDY_DIRECTOR
affiliation: Larissa University Hospital
name: Metaxia Bareka, Medicine
role: STUDY_CHAIR
affiliation: Alexandroupoli University Hospital
name: Christos Iatrou, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Theophilos Karachalios, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Marina Simaioforidou, Medicine
role: STUDY_CHAIR
References:
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citation: 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.
citation: Muzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993
citation: 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.
citation: 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.
citation: 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.
citation: 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.