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.: PACTR201711002756172 Date of Approval: 11/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Subcutaneous wound infiltration with tramadol for post cesarean section pain relief: a randomized controlled trial
Official scientific title Tramsdol vs lidocaine vs placebo wound infiltration for post cesarean section pain relief: a randomized controlled trial
Brief summary describing the background and objectives of the trial To evaluate the impact of subcutaneous infiltration before skin closure in cesarean section on postoperative pain relief
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postoperative pain,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 22/11/2017
Actual trial start date 22/11/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 99
Actual target sample size (number of participants) 99
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 randomization using a randomization table created by a computer software program Sealed opaque envelope Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Saline Saline subcutaneous infiltration 33 Placebo
Experimental Group Lidocaine Lidocaine subcutaneous infiltration 33
Experimental Group Tramadol Tramadol subcutaneous infiltration 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women undergoing elective cesarean section Major medical disorders Bleeding tendency Allergy to medication Drug addiction 20 Year(s) 35 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 01/11/2017 Air-Force Specialized
Ethics Committee Address
Street address City Postal code Country
El Teseen (Ninety street) Cairo not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative pain 2 hours 4 hours 6 hours 12 hours 24 hours
Secondary Outcome need for post-operative analgesia 2 hours 4 hours 6 hours 12 hours 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6th University Central axis Cairo not available Egypt
Air-Force specialized Hospital El Teseen (ninety street) Cairo not available Egypt
Ain-Shams University Abassiya Cairo not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Air-Force Specialized Hospital El Teseen (ninety street) Cairo not available Egypt
Air-Force Specialized Hospital El Teseen (ninety street) Cairo not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Air-Force Specialized Hospital El Teseen (ninety street) Cairo not available Egypt Hospital
Primary Sponsor Ain-Shams University Abassiya Cairo not available Egypt University
COLLABORATORS
Name Street address City Postal code Country
October 6th University Central axis 6th October- Giza not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October - Giza not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Ahmed Sherif ahmedgyna@yahoo.com +201227960980 Abassita
City Postal code Country Position/Affiliation
Cairo not available Egypt Ain-Shams Universaity
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October - Giza not available Egypt October 6th University
REPORTING
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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