Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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During Laparoscopic cholecystectomy, carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis. CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.

Detailed Description
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Laparoscopic surgery is being increasingly recognized for its advantages of minimal invasiveness. mild postoperative pain, short length of hospitalization and rapid recovery and is widely used in general surgery, obstetrics. gynecology and urology. Laparoscopic cholecystectomy (LC) has become the gold standard for surgically treating benign diseases of the gallbladder. During carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis. CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.

Official Title
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Stellate Ganglion Block Efficacy in Control of Arrhythmia and Cardiovascular Changes in Addition to, Postoperative Analgesia in Laparoscopic Cholecystectomy

Conditions
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Arrythmia, Pain, Acute

Intervention / Treatment
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* Procedure: right stellate ganglion block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 -60 years american society of anesthesiologists status I-II Scheduled for elective laparoscopic cholecystectomy Exclusion Criteria: Patients with chronic renal dysfunction. Patients with hypo/hyper-thyroidism. Patients with diseases of the autonomic and central nervous systems. Patients with cardiopulmonary dysfunction. Patients with history of treatment with long-term oral tranquilizers.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stellate Ganglion block group<br>will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance | Procedure: right stellate ganglion block<br>* The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome.<br>|
| No Intervention: Control group<br>will include 20 patients: a control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia | the incidnese of Arrhythmia | introperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrythmia, Acute pain