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.: PACTR201706002029303 Date of Approval: 09/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ketamine versus midazolam with bupivacaine in sonar guided supraclavicular brachial plexus block
Official scientific title Ketamine versus midazolam with bupivacaine in sonar guided supraclavicular brachial plexus block
Brief summary describing the background and objectives of the trial Comparison between using ketamin and bupivacaine versus midazolam and bupivacaine on their effect on onset and duration of sensory and motor block and their effect on VAS ,sedation score and meanarterial blood pressure and pulse
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,PAIN
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Comparison between using ketamin and bupivacaine versus midazolam and bupivacaine
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 10/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 35
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group u.s guided supraclavicular nerve block once once ketamine added to bupivacaine in us guided supraclavicular nerve block 35
Experimental Group u.s guided supraclavicular nerve block once once midazolam added to bupivacaine in u.s guided supraclavicular nerve block 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA1and2 Operation of upper limbs Coagulopathy Mental retardation Patient refusal Pregnancy 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 27/05/2015 faculty of medecine
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sedation and VAS score onset and duration of sensory and motor block Preoperative intraooerative and postooerative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital Elgeishr st. Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital Elgeish st. tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital Elgeish st. tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohahamed zakarea wfa Elgeish st. tanta 31527 Egypt
mona blough el mourad Elgeish st. tanta 31527 Egypt
ayman abd al maksoud Elgeish st. tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed zakarea dr.mohameszakarea@gmail.com 01017397773 elgeish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt anesthesia resident at tanta university hospital
Role Name Email Phone Street address
Public Enquiries mona blough monamorad80@gmail.com 01225124747 elgeish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of anesthesia faculty of medecine tanta university
Role Name Email Phone Street address
Scientific Enquiries ayman abd al maksoud dr.ayman_maksoud@gmail.com 01204009690 elgeish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt prof of anesthesia faculty of medecine tanta university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information