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.: PACTR202009696239961 Date of Approval: 15/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TAP block versus I TAP using the same dose of local anesthetic in elective cesarean section
Official scientific title US-guided Classical TAP block versus US-guided I TAP using the same dose of local anesthetic in elective cesarean section
Brief summary describing the background and objectives of the trial Pain after cesarean section is usually described as moderate to severe by most patients and failure to adequately treat may affect mother-baby bonding, care of baby, and breastfeeding. Currently, a multimodal analgesic technique involving abdominal nerve block with parenteral analgesics is becoming popular for these patients. Transverse abdominis plane (TAP) block is a recently introduced regional technique that blocks abdominal wall neural afferents between T6 and L1 and thus can relieve pain associated with an abdominal incision. The aim of the work is to compare the efficacy of classical TAP block versus classical TAP block and ilioinguinal nerve block using the same dose of bupivacaine on postoperative pain score, opioid consumption, and patient satisfaction in elective cesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2020
Actual trial start date
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP and Ilioinguinal 2o ml of bupivacaine 0.5% for classical TAP plus 5 ml of bupivacaine 0.5% for ilioinguinal nerve block Once 20 ml of bupivacaine 0.5% will be injected between the transversus abdominis muscle and internal oblique muscle and 5 ml of the same concentration for blocking the ilioinguinal nerve 100
Control Group Classical TAP 25 ml of bupivacaine 0.5% once 25 ml of bupivacaine 0.5% will be injected between the transversus abdominis muscle and internal oblique muscle 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women scheduled for elective cesarean section Patient refusal Coagulopathy Infection at the site of injection Allergy to bupivacaine Adult: 19 Year-44 Year 20 Year(s) 45 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 18/06/2020 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 champlion street elmessalah Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analog score (VAS score) assessment Every hour in the firth 4 hours postoperative Then every 4 hours for the rest of 24 postoperative hours
Secondary Outcome Opioid consumption At the end of the first 24 hours
Secondary Outcome Patient satisfaction Immediately before discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Sidney Keil hospital Private obstetric hospital 16 Abdelhamid elabadi st. roushdy Alexandria Alexandria 21529 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Wessam alamrawy 1 mostafa kamel street Montaza Alexandria 21637 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University 17 champlion street elmessalah Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed elattar 47 sultan Hussein st. flat 203 azarita Alexandria 21521 Egypt
Wessam alamrawy 1 mostafa kamel street Alexandria Egypt montaza Alexandria 21637 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elattar Ahmed.alattar@alexmed.edu.eg 01222144835 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria Univlersity
Role Name Email Phone Street address
Scientific Enquiries Wessam Alamrawy Wesam_amrawy@yahoo.com 01280998606 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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