Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Arrythmia
• Intervention / Treatment: Procedure: right stellate ganglion block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stellate Ganglion block group; 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; 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.
No Intervention: Control group; will include 20 patients: a control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute pain; Arrythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Arrhythmias, Cardiac; Acute Pain
• Other Study ID Numbers: IRB17101436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No