NCT03181672

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

June 1, 2017

Last Update Submit

June 7, 2017

Conditions

Keywords

Stellate ganglion block Tourniquet reaction

Outcome Measures

Secondary Outcomes (1)

  • Complication of puncture

    2 hours in perioperative period

Study Arms (2)

Stellate ganglion block

ACTIVE COMPARATOR

Stellate ganglion block

Procedure: Stellate ganglion block

control group

PLACEBO COMPARATOR

Deltoid muscle injection

Procedure: control group

Interventions

Stellate ganglion block with 1% lidocaine 10ml

Stellate ganglion block
control groupPROCEDURE

Deltoid muscle injection with 1% lidocaine 10ml

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of anesthesiologists Grade 1-3 Patients
  • undergoing lower limb surgery under general anesthesia
  • should be treated with tourniquet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

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

    PMID: 15101858BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tie Xu, MD

    The Affiliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Shuangshuang Meng, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 9, 2017

Study Start

June 2, 2017

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

IPD will be available when this trial is finished and the article have been published.

Locations