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.: PACTR201511001204347 Date of Approval: 16/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided Segmental Thoracic spinal anesthesia for percutaneous nephrolithotomy
Official scientific title Ultrasound guided Segmental Thoracic spinal anesthesia for percutaneous nephrolithotomy
Brief summary describing the background and objectives of the trial Percutaneous nephrolithotomy (PCNL) is an established procedure of choice for renal stones > 2cm. PCNL are usually done under general anesthesia. However, there are few studies regarding the efficacy of spinal anesthesia for PCNL and no studies regarding the efficacy of segmental thoracic spinal anesthesia for PCNL
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied regional anesthesia for nephrolithotomy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 30/09/2015
Actual Last follow-up date 30/09/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guided segmental thoracic block 7.5 mg bupivacaine 0.5% single shot ultrasound guided segmental thoracic block 30
Control Group general anesthesia 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiology (ASA) physical status classification I or II. age 20¿60 years a body mass index above 35 kg/m2, surgery time more than 120 min, and the presence of any contraindication to spinal anesthesia. 20 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
No medical research institute
Ethics Committee Address
Street address City Postal code Country
165 horreya road Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome patient satisfaction once
Primary Outcome discharge time when meeting the discharge criteria, patients are discharged from the PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed ellakany mlakany@yahoo.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-Alexandria university
Role Name Email Phone Street address
Public Enquiries Andre van zundert vanzundertandre@gmail.com +61 4 17654348 Roayl Brisban and Womens Hosp - Anesthesia, Ned Hanlon Bldng Level4, Herston Campus
City Postal code Country Position/Affiliation
Brisbane 4029 Australia professor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Sherif Abdelhamid dr_shereif@hotmail.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-medical research institute-Alexandria 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information