Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201511001269388 Date of Approval: 15/09/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Subfascial versus extrafascial stellate block
Official scientific title Subfascial versus extrafascial ultrasound guided stellate ganglion block in postmastectomy sympathetically mediated pain
Brief summary describing the background and objectives of the trial Subfascial versus extrafascial ultrasound guided stellate ganglion block in postmastectomysympathetically mediated pain Introduction Stellate ganglion block (SGB) is a common diagnostic tool for sympathetically mediated pain and vascular insufficiency of the upper extremities. The anatomical course of the cervical sympathetic trunk (CST) relative to the longuscolli muscle and the prevertebral fascia is continuously disputed. This work aims at comparing subfascial and extrafascial stellate ganglion block regarding difference in pain score improvement. In addition, an attempt was made to develop a safe and reliable injection technique. Methods fifty patients suffering from post mastectomy pain randomized into two groups. All of them will get US guided stellate block. The first group gets stellate ganglion block at subfascial plane while the second group gets extrafascial block. Conclusion: Subfasial stellate block has higher success rate in terms of temperature rise and pain relief. In addition to more efficient spread to T2 and more detectable spread avoiding somatic nerves.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postmastectomy sympathetically mediated pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 26/11/2014
Actual trial start date 07/12/2014
Anticipated date of last follow up 07/06/2015
Actual Last follow-up date 05/07/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a table sealed envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group extrafascial stellate block 3 ml of local anesthetic mixture single injection us guided extrafascial stellate block 25 Active-Treatment of Control Group
Experimental Group subfascial stellate block 3 ml of local anathetic single injection us guided subfascial stellate block 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 20 to 60 years upper limb moderate to severe sympathetically mediated pain following epsilateral mastectomy ASA physical status 1 & 2. Coagulopathy Local infection Mental disorders. 20 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/11/2014 institutional review board decision , national cancer institute, cairo university
Ethics Committee Address
Street address City Postal code Country
kasr eini st,1 cairo 11796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome temoerature rise more than 2 degrees within 300 seconds of injection
Secondary Outcome VAS, Hoarner's syndrome within 300 seconds
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national cancer institute kasr eini st, 1 cairo 12211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national cancer institute , cairo university kasr eini st, 1c cairo 12211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national cancer institute , cairo university kasr eini st, 1 cairo 12211 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed adly elramely zizinia city, 21, new cairo cairo 11835 Egypt
Ahmed Abdelaal Ahmed Mahmoud 39 Mousa Ebn Nousir Street, 7th district, Nasr city, cairo 11471 Egypt
ahmed shaker ragab cairo Egypt
Ahmed Abdelaal Ahmed Mahmoud 39 Mousa Ebn Nousir Street, 7th district, Nasr city, cairo 11471 Egypt
ahmed shaker ragab cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed elramely mramely@hotmail.com 00201005125124 zizinia city 21, new cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt lecturer of anesthesia and pain management national cancer institute cairo university
Role Name Email Phone Street address
Public Enquiries ahmed elkhateeb carnitin7@yahoo.com 00201113308866 mosa ebn noser st,39, naser city
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecture of anesthesia, beni suef university
Role Name Email Phone Street address
Scientific Enquiries mohamed elramely mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt lecturer of anesthesia and pain management, Cairo University
REPORTING
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