Stellate Ganglion Block on Tourniquet Response

Stellate Ganglion Block Clinical Trial

Official title:

Influence of Stellate Ganglion Block on Tourniquet Response in Lower Limbs.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181672
• Other study ID #: XYFY2017-KL012-01
• Status: Recruiting
• Phase: N/A
• First received: June 1, 2017
• Last updated: June 7, 2017
• Start date: June 2, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Tie Xu, MD
• Phone: 13952110889
• Email: xutie889[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb Department of orthopedics.

Description:

Select elective general anesthesia in 100 cases of lower extremity Department of orthopedics surgery patients were randomly divided into SGB group and control group, SGB group received anesthesia before the right stellate ganglion block intervention, the control group underwent right deltoid muscle injection, changes in hemodynamics in two groups were recorded in heart rate, blood pressure, and before anesthesia, after intubation 3min 1H, a tourniquet, tourniquet release before and after tourniquet release 3min, 30min, changes in blood physiological analysis. The effect of stellate ganglion block on tourniquet response during perioperative period was observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• American Society of anesthesiologists Grade 1-3 Patients

• undergoing lower limb surgery under general anesthesia

• should be treated with tourniquet

Exclusion Criteria:

• Tourniquet application time is less than 1h, greater than 1.5h

• Abnormal coagulation function

• perioperative application of hormone

• lidocaine allergy

• can not cope with nerve block

• nerve block failure

• minimally invasive surgery

Related Conditions & MeSH terms

• Ganglion Cysts
• Stellate Ganglion Block

Intervention

Procedure:
• Stellate ganglion block
Stellate ganglion block with 1% lidocaine 10ml
• control group
Deltoid muscle injection with 1% lidocaine 10ml

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Arai YC, Ogata J, Matsumoto Y, Yonemura H, Kido K, Uchida T, Ueda W. Preoperative stellate ganglion blockade prevents tourniquet-induced hypertension during general anesthesia. Acta Anaesthesiol Scand. 2004 May;48(5):613-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	mmHg	2 hours in perioperative period
Primary	heart rate	bpm	2 hours in perioperative period
Primary	Lac	blood gas analysis mmol/L	One minute after the radial artery puncture, the tourniquet was applied for 1 hours and the tourniquet was released 3 minutes after the tourniquet release 30 minutes
Primary	cortisol	ELISA ng/ml	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	norepinephrine	ELISA nmol/L	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	ET-1	ELISA ng/L	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	MDA	ELISA nmol/ml	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	SOD	ELISA µg/L	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	IL-6	ELISA pg/ml	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	cTn-T	ELISA µg/L	One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet
Primary	postoperative pain	VAS score	hour 1?hour 6?hour 24?hour 48 after operation
Secondary	Complication of puncture	bleeding?nerve injury?	2 hours in perioperative period