Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy
Primary Purpose
Arrythmia, Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
right stellate ganglion block
Sponsored by
About this trial
This is an interventional treatment trial for Arrythmia focused on measuring Arrythmia, Acute pain
Eligibility Criteria
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.
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Stellate Ganglion block group
Control group
Arm Description
will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance
will include 20 patients: a control group
Outcomes
Primary Outcome Measures
Arrhythmia
the incidnese of Arrhythmia
Secondary Outcome Measures
Postoperative pain
Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04837495
Brief Title
Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy
Official Title
Stellate Ganglion Block Efficacy in Control of Arrhythmia and Cardiovascular Changes in Addition to, Postoperative Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Pain, Acute
Keywords
Arrythmia, Acute pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion block group
Arm Type
Active Comparator
Arm Description
will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance
Arm Title
Control group
Arm Type
No Intervention
Arm Description
will include 20 patients: a control group
Intervention Type
Procedure
Intervention Name(s)
right stellate ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arrhythmia
Description
the incidnese of Arrhythmia
Time Frame
introperative period
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy
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