Stellate Ganglion Block on Tourniquet Response

• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03181672
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stellate Ganglion Block	Procedure: Stellate ganglion block; Procedure: control group	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Stellate Ganglion Block on Tourniquet Response in Lower Limbs.
• Actual Study Start Date: Jun 2, 2017
• Anticipated Primary Completion Date: Jun 30, 2018
• Anticipated Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stellate ganglion block 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

Outcome Measures

Primary Outcome Measures

1. blood pressure [2 hours in perioperative period]

   mmHg

2. heart rate [2 hours in perioperative period]

   bpm

3. Lac [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

4. cortisol [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

5. norepinephrine [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

6. ET-1 [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

7. MDA [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

8. SOD [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

9. IL-6 [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

10. cTn-T [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

11. postoperative pain [hour 1、hour 6、hour 24、hour 48 after operation]

    VAS score

Secondary Outcome Measures

1. Complication of puncture [2 hours in perioperative period]

   bleeding、nerve injury、

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000

Sponsors and Collaborators

• The Affiliated Hospital of Xuzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: The Affiliated Hospital of Xuzhou Medical University
• ClinicalTrials.gov Identifier: NCT03181672
• Other Study ID Numbers: XYFY2017-KL012-01
• First Posted: Jun 9, 2017
• Last Update Posted: Jun 9, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Hospital of Xuzhou Medical University: Stellate ganglion block Tourniquet reaction
• Additional relevant MeSH terms: Ganglion Cysts; Synovial Cyst

Study Results

No Results Posted as of Jun 9, 2017