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.: PACTR201711002719245 Date of Approval: 23/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title compairing stellate ganglion block with thoracic paravertebral block in acute upper limb ischemia
Official scientific title Ultrasound guided T2 & T3 paravertebral block versus ultrasound guided stellate block in acute upper limb ischemia.
Brief summary describing the background and objectives of the trial Unintentional intra-arterial injection of medication, either iatrogenic or self-administered, is a source of considerable morbidityachieve . Delivery of certain medications via arterial access has led to clinically important sequelae, including paresthesias, severe pain, motor dysfunction, compartment syndrome, gangrene, and limb loss..(stellate gangalion block Stellate ganglion block is possible method to produce sustained arterial and venous vasodilation, with many complications up to cardiac arrest ,t2 t3 thoracaic paravertebral block result in sympathectomy prevent upper ischemic limb from amputation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied upper limb ischemia ,stelate ganglion block ,t2 t3 thoracic para vertebral block ,
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 26/10/2017
Actual trial start date 29/10/2017
Anticipated date of last follow up 26/12/2017
Actual Last follow-up date 19/10/2017
Anticipated target sample size (number of participants) 43
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
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 randomization using rolling dice Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultasounded stellate ganglon block 10cm 0.25Bupivacaine plus 16mg dexamethasone ultra sound guided stellate ganglion block 20 Active-Treatment of Control Group
Experimental Group ultrasound guided t2 t3 paravertbral block 10cm 0.25% bupivacaine plus 16 mg dexamethasone ultasound guided t2 t3 paravertbral block 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 1-11 male or female , 18 -60 years ,the anathestaist will requested for patient with sever pain after unintentional inta arterial injection of drug causing upper limb ischemia with exclustion criteria Exclusion Criteria: American Society of Anesthesia (ASA) III-IV, renal insufficiency (creatinine > 1.5 mg/dL),a history of opioid dependence, pregnancy, morbid obesity (body mass index > 40 kg/m2); chronic analgesia, history of sensitivty to local anathetic , bleeding disorders or reciving anticoagulant, spine or chest wall deformity 18 Year(s) 60 Year(s) Both
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 04/11/2017 zagazig faculty of medicne
Ethics Committee Address
Street address City Postal code Country
zagazig hospital university strreet zagazig +20 Egypt
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 10/10/2017 zagazig faculty of medicine
Ethics Committee Address
Street address City Postal code Country
zagazig hospital university street zagazig +20 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome complete pain relife onset of analgesia and vasodilation
Secondary Outcome horner syndrome ,hypotention, back pain, phrenic nerve ijnjury from time of injection till time of pain relife of the upper limbe
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
zagazig University hospital zagazig University hospital street zagazig +20 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
zagazig university hospitals zagazig hospital university street zagazig +20 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zagazig university hospitals zagazig hospital universty street zagazig +20 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ahmed s hegab anesthesia department, zagazig university zagazig +20 Egypt
gehan fawzy ezz al khalifa al rashed zagazig +20 Egypt
heba kawmia zagazig +20 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gehan Ezz fawzyezz@yahoo.com +01066252038 al khalifa al rashed hay al salam bulding No 28
City Postal code Country Position/Affiliation
zagazig +20 Egypt lecturer of anathesia and surgical icu
Role Name Email Phone Street address
Public Enquiries Heba el gendi heba_elgendi@yahoo.com 01000143938 al kawmia street borg al doha
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer of anathesia and surgical icu
Role Name Email Phone Street address
Public Enquiries Ahmed Hegab ahmedhegab66@yahoo.com 01000089347 ahmed ismail street
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer
Role Name Email Phone Street address
Scientific Enquiries Ahmed hegab ahmedhegab66@yahoo.co 0100089347 ahmed ismaeel street al harameen hospital buliding
City Postal code Country Position/Affiliation
zagazig +20 Egypt lectruer anathesia and surical
REPORTING
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