Stellate Ganglion Block on Tourniquet Response

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

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

Study Overview

• Status: Unknown
• Conditions: Stellate Ganglion Block
• Intervention / Treatment: Procedure: Stellate ganglion block; Procedure: control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tie Xu, MD; Phone Number: 13952110889; Email: xutie889@163.com
• Study Contact Backup: Name: Shuangshuang Meng, bachelor; Phone Number: 15862167035; Email: mengss@163.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Shuangshuang Meng, bachelor; Phone Number: 15862167035; Email: mengss@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stellate ganglion block	Procedure: Stellate ganglion block; Stellate ganglion block with 1% lidocaine 10ml
Placebo Comparator: control group; Deltoid muscle injection	Procedure: control group; Deltoid muscle injection with 1% lidocaine 10ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	mmHg	2 hours in perioperative period
heart rate	bpm	2 hours in perioperative period
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
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
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
	n nitrate reductase method μmol/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
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
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
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
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
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
postoperative pain	VAS score	hour 1、hour 6、hour 24、hour 48 after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication of puncture	bleeding、nerve injury、	2 hours in perioperative period

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Investigators: Study Director: Tie Xu, MD, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

General Publications

• 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. doi: 10.1111/j.0001-5172.2004.00389.x.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stellate ganglion block Tourniquet reaction
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: XYFY2017-KL012-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available when this trial is finished and the article have been published.

Drug and device information, study documents

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