Effect of Interscalene Block on Heart Rate Variability (HRV)

Autonomic Nervous System Clinical Trial

Official title:

Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185457
• Other study ID #: HRVShoulder
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: October 26, 2012
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System
• Beach Chair Position
• HRV
• Interscalene Block
• Shoulder Surgery

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (7)

Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. Review. — View Citation

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

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. — View Citation

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. — View Citation

RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Interscalene block and beach chair positioning	Effect of interscalene block on hypotension during beach chair positioning	2 years	No
Secondary	Interscalene block and beach chair positioning	Effect of interscalene block on bradycardia during beach chair positioning	2 years	No