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.: PACTR201710002642374 Date of Approval: 25/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Spinal anesthesia during outpatient tumscent liposuction
Official scientific title Prospective study of conventional versus diluted spinal for lower extremity tumscent liposuction
Brief summary describing the background and objectives of the trial We will study spinal anesthesia in outpatient, 120 pts. Will be randomly choosen and diveded into two group, in both groups, volume of local anesthetic will be the same but with different concentration and dose, spinal is not recommended in outpatient anesthesia because of prolonged recovery, so we will study the effect of dilution on recovery and discharge time as well as the ability of pt to stand,if needed for better cosmic result.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CS and DS
Disease(s) or condition(s) being studied Conventional vs diluted spinal anesthesi for liposuction,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/09/2017
Actual trial start date
Anticipated date of last follow up 27/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status 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 Computer-generated program Sealed opaque envelops Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated program Sealed opaque envelops Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated program Sealed opaque envelops Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated program Sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Conventional spinal 12.5-15 mg Once With the start of liposuction procedure 60 Active-Treatment of Control Group
Experimental Group Diluted spinal 5-7.5 mg bupivacaine Once With the start of liposuction procedure 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Asa l,ll, Age 18 to 50, Both genders, BMI < 35 With lower extremity liposuction Patient refusal, Sever respiratory disease, Sever cardiovascular problem , Coagulopathy, Other sever systemic disease and Infection at the site of injection 18 Year(s) 50 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 18/07/2017 Faculty of medicine , elmenoufiya university
Ethics Committee Address
Street address City Postal code Country
25 yasin abdelghafar street Shibin alkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Estimation of recovery time and discharge readiness Recovery time Home readiness time
Secondary Outcome Hemodynamic changes, pulse blood pressure, spo2 Baseline, every 5 minutes during first hour,then every 10 minutes allover the procedure
Secondary Outcome Motor block and sensory block After 10 and 20 minutes after performing the block
Secondary Outcome Patient satisfaction Allover the procedure
Secondary Outcome Complication Allover the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elmenoufiya university hospital 25 yasin abdelghafar street Shibin elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine 25 yasin abdelghafar street Shibin elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine 25 yasin abdelghafar street Shibin elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hanaa Abo-Elfotoh elfeky 25 yasin abdelghafar street Shibin elkom 002048 Egypt
Hazem ezz at elsersy 25 yasin abdelghafar street Shibin alkom 002048 Egypt
Nadia mohee eld in bahgat 25 yasin abdelghafar street Shibin alkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanaa Elfeky hanaafotoh@yahoo.com 00971508987298 25 yasin abdelghafar street
City Postal code Country Position/Affiliation
Shibin alkom Egypt
Role Name Email Phone Street address
Public Enquiries Hazem Elsersy hazelsersy@Hotmail.com 00201091096655 25 yasin abdelghafar street
City Postal code Country Position/Affiliation
Shibin alkom Egypt
Role Name Email Phone Street address
Scientific Enquiries Nadia Bahgat dr_nmbahgat@yahoo.com 0020122850598 25 yasin abdelghafar street
City Postal code Country Position/Affiliation
Shibin alkom Egypt
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