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Stellate Ganglion Block on Tourniquet Response

Primary Purpose

Stellate Ganglion Block

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
control group
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stellate Ganglion Block focused on measuring Stellate ganglion block Tourniquet reaction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Stellate ganglion block

control group

Arm Description

Stellate ganglion block

Deltoid muscle injection

Outcomes

Primary Outcome Measures

blood pressure
mmHg
heart rate
bpm
Lac
blood gas analysis mmol/L
cortisol
ELISA ng/ml
norepinephrine
ELISA nmol/L
n nitrate reductase method μmol/L
ET-1
ELISA ng/L
MDA
ELISA nmol/ml
SOD
ELISA μg/L
IL-6
ELISA pg/ml
cTn-T
ELISA μg/L
postoperative pain
VAS score

Secondary Outcome Measures

Complication of puncture
bleeding、nerve injury、

Full Information

First Posted
June 1, 2017
Last Updated
June 7, 2017
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03181672
Brief Title
Stellate Ganglion Block on Tourniquet Response
Official Title
Influence of Stellate Ganglion Block on Tourniquet Response in Lower Limbs.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical 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
To investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb Department of orthopedics.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block
Keywords
Stellate ganglion block Tourniquet reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block
Arm Type
Active Comparator
Arm Description
Stellate ganglion block
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Deltoid muscle injection
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
Stellate ganglion block with 1% lidocaine 10ml
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
Deltoid muscle injection with 1% lidocaine 10ml
Primary Outcome Measure Information:
Title
blood pressure
Description
mmHg
Time Frame
2 hours in perioperative period
Title
heart rate
Description
bpm
Time Frame
2 hours in perioperative period
Title
Lac
Description
blood gas analysis mmol/L
Time Frame
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
Title
cortisol
Description
ELISA ng/ml
Time Frame
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
Title
norepinephrine
Description
ELISA nmol/L
Time Frame
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
Description
n nitrate reductase method μmol/L
Time Frame
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
Title
ET-1
Description
ELISA ng/L
Time Frame
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
Title
MDA
Description
ELISA nmol/ml
Time Frame
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
Title
SOD
Description
ELISA μg/L
Time Frame
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
Title
IL-6
Description
ELISA pg/ml
Time Frame
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
Title
cTn-T
Description
ELISA μg/L
Time Frame
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
Title
postoperative pain
Description
VAS score
Time Frame
hour 1、hour 6、hour 24、hour 48 after operation
Secondary Outcome Measure Information:
Title
Complication of puncture
Description
bleeding、nerve injury、
Time Frame
2 hours in perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tie Xu, MD
Phone
13952110889
Email
xutie889@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuangshuang Meng, bachelor
Phone
15862167035
Email
mengss@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tie Xu, MD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangshuang Meng, bachelor
Phone
15862167035
Email
mengss@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available when this trial is finished and the article have been published.
Citations:
PubMed Identifier
15101858
Citation
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.
Results Reference
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Stellate Ganglion Block on Tourniquet Response

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