Stellate Ganglion BlockNCT03181672
Stellate Ganglion Block on Tourniquet Response
A study testing Stellate ganglion block in people with Stellate Ganglion Block, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
To investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb Department of orthopedics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of anesthesiologists Grade 1-3 Patients
- undergoing lower limb surgery under general anesthesia
- should be treated with tourniquet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Shuangshuang Meng, bachelor, 15862167035, mengss@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stellate Ganglion Block
- Being tested
- Stellate ganglion block, control group
- Keywords
- Stellate ganglion block Tourniquet reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
Stellate ganglion block with 1% lidocaine 10ml
control groupProcedure or surgery
Deltoid muscle injection with 1% lidocaine 10ml
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block | Active comparator | Stellate ganglion block Receives: Procedure: Stellate ganglion block |
| control group | Placebo comparator | Deltoid muscle injection Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
mmHg
Measured: 2 hours in perioperative period
heart rate
bpm
Measured: 2 hours in perioperative period
Lac
blood gas analysis mmol/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: hour 1、hour 6、hour 24、hour 48 after operation
Secondary outcomes (1)
Complication of puncture
bleeding、nerve injury、
Measured: 2 hours in perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start2 Jun 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tie Xu, MD, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181672
- Sponsor's protocol ID
- XYFY2017-KL012-01
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available when this trial is finished and the article have been published.
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.
PubMed 15101858
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Stellate Ganglion Block on Tourniquet Response in Lower Limbs.
- ClinicalTrials.gov ID
- NCT03181672
- Acronym / sponsor ID
- XYFY2017-KL012-01
- Conditions
- Stellate Ganglion Block
- Keywords
- Stellate ganglion block Tourniquet reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block | Active comparator | Procedure: Stellate ganglion blockStellate ganglion block |
| control group | Placebo comparator | Procedure: control groupDeltoid muscle injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of anesthesiologists Grade 1-3 Patients
- undergoing lower limb surgery under general anesthesia
- should be treated with tourniquet
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate ganglion blockStellate ganglion block with 1% lidocaine 10ml | Procedure or surgery | Stellate ganglion block |
| control groupDeltoid muscle injection with 1% lidocaine 10ml | Procedure or surgery | control group |
Primary outcome
blood pressure
Time frame: 2 hours in perioperative period
mmHg
heart rate
Time frame: 2 hours in perioperative period
bpm
Lac
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
blood gas analysis mmol/L
cortisol
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
ELISA ng/ml
norepinephrine
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
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
n nitrate reductase method μmol/L
ET-1
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
ELISA ng/L
MDA
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
ELISA nmol/ml
SOD
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
ELISA μg/L
IL-6
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
ELISA pg/ml
cTn-T
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
ELISA μg/L
postoperative pain
Time frame: hour 1、hour 6、hour 24、hour 48 after operation
VAS score
1 secondary outcome
Complication of puncture
Time frame: 2 hours in perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Background: PubMed 15101858Arai 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.
- Individual participant dataSharing planned: No. IPD will be available when this trial is finished and the article have been published.
Related trials for Stellate Ganglion Block
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation
Not yet recruiting
Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
Stellate Ganglion Block, Prolonged Disorders of Consciousness
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruiting
Effect of Stellate Ganglion Block on Sleep Quality in Patients With Depression
Sleep and Circadian Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tie Xu, MD study director
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Stellate Ganglion Block, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tie Xu, MD (13952110889, xutie889@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 2 hours in perioperative period). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03181672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.