Clinical trial of Comparison of effectiveness of stellate ganglion block under the guidance of fluoroscopy and ultrasonography guidance in upper extremity complex regional pain syndrome
In this study 14 patients with sympathetic complex regional pain syndrome in upper extremities who were visited in pain clinic were included. Patients in a randomized method with block randomization divided in two groups ( with sonograpgy or fluoroscopic guidance ). The purpose of the study is the pain relieve and rise the temperature in the affected limb. Fourteen patients with upper extremities sympathetic maintain pain were candidates for Stellate ganglion block with block randomization divided in two 7 patients groups . First group will be blocked under fluoroscopic guidance and second group will be blocked under ultrasound guidance. Inclusion criteria: Type 1 and Type 2 CRPS, post-herpetic neuralgia, head and neck and upper limbs cancer pain . Exclusion criteria: anticoagulant therapy, pneumothorax or pneumonectomy in other side, recent MI . The final aims after stellate ganglion block is VAS<3 during minimal daily activities .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081410599N1
Registration date:2015-01-30, 1393/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-30, 1393/11/10
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Iran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Comparison of effectiveness of stellate ganglion block under the guidance of fluoroscopy and ultrasonography guidance in upper extremity complex regional pain syndrome
Public title
Upper extremity pain management with stellate ganglion block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type1 and 2 CRPS, post-herpetic neuralgia, head and neck and upper limbs cancer pain, vascular pain, hyperhydrosis, vascular vasospasm, vasculopathy related Menier disease, post traumatic syndromes which cause cyanosis, cold hydrosis and inflammation. Exclusion criteria : anticoagulant therapy, pneumothorax or pneumonectomy in other side, recent MI, glaucoma and cardiac conduction anomaly.
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Street address
Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat exp way
City
Tehran
Postal code
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
93-02-30-24632-103514
2
Ethics committee
Name of ethics committee
Street address
City
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Health conditions studied
1
Description of health condition studied
Upper Extremities Complex regional pain syndrome
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
Pain
Timepoint
First , 6 hours and 2-7 days after that
Method of measurement
VAS ( standard tools for pain assessment)
2
Description
Affected upper extremity temperature
Timepoint
First , 6 hours and 2-7 days after that
Method of measurement
Thermometer
Secondary outcomes
1
Description
Conjunctival and nasal congestion
Timepoint
Immediately after injection
Method of measurement
Visual
Intervention groups
1
Description
Flouroscopic guide stellate ganglion block: After select the patient with block randomization method, first put the C-ARM in AP view and specify the C6 or C7 vertebra. The desired location is the junction between the transverse process and the body of C6 or C7 vertebra. Five to 10 cm Needle plug to the extension tube while contact bone occurred. The needle will be positioned at anterolateral to the vertebral body. Longus colli located at lateral to vertebral body and medial to transverse process. Be aware that needle be in contact with the bone to avoid the longus colli injection. If paresthesia will occurred the needle withdrawn and repositioned in another place.
Category
Treatment - Other
2
Description
Sono guide stellate ganglion block: After select the patient with block randomization method,the patient is placed in supine position with little head extension to contralateral side . We used the linear high frequency transducer (6-13 mhz) at C6 cervical vertebra. we must see the cutting of the anatomical structures such as the C6 transverse process, longus colli muscle, prevertebral fascia, thyroid gland and carotid artery . The needle might be the path lateral to the carotid artery and is the preferred path.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh “St.”,Sattarkahn “Ave.”, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Ali javad Mousavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat “Exp.” way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
karim Hemati
Position
Second administrator-Associated professor of Anesthesiology, Pain Fellowship
Other areas of specialty/work
Street address
Department of pain, 4th Floor, Rasool Akram Hospital, Niayesh “St.”, Sattarkahn “St.”, Tehran
City
Tehran
Postal code
Phone
+98 21 6655 3921
Fax
Email
khematy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Assistant professor of Anesthesiology - Pain FellowShip
Other areas of specialty/work
Street address
Department of pain, 4th Floor, Rasool Akram Hospital, Niayesh “St.”, Sattarkahn “St.”, Tehran, Iran. P.O box: 14455- 364
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
popak-rah@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Karim Hemati
Position
Associated professor of Anesthesiology - Pain Fellow Ship
Other areas of specialty/work
Street address
4th Floor, Department of pain, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St.,Sattarkahn Ave, Tehran, Iran. P.O box: 14455- 364
City
Tehran
Postal code
Phone
+98 21 6655 3921
Fax
Email
khematy@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)