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.: PACTR201605001605319 Date of Approval: 26/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of the ilioinguinal-iliohypogastric block after unilateral inguinal hernia repair
Official scientific title Comparison of the effectiveness of the ilioinguinal-iliohypogastric block and the transversus abdominis plane block for analgesia after unilateral inguinal hernia repair
Brief summary describing the background and objectives of the trial Ilioinguinal-iliohypogastric block (II/IH) and TAP block were regional block techniques that provides effective analgesia after some abdominal surgery. In this study, we compared the analgesic efficacy of the ultrasound (US) guided II/IH block and TAP block for analgesia after unilateral inguinal hernia repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2016
Actual trial start date 22/04/2016
Anticipated date of last follow up 26/04/2016
Actual Last follow-up date 26/04/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a radomisation table created by Random allocation software Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Transversus Abdominis Plane Block 30 ml of Bupivacaine 0.125% single Injection after intubation Ultrasound TAP block 30 Active-Treatment of Control Group
Experimental Group Ilioinguinal-iliohypogastric block 30 ml of Bupivacaine 0.125% single Injection after intubation Ultasound BIIH Block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II patients. Patients scheduled for unilateral hernia repair. Allergy to local anesthetics. Body Mass Index more than 30. 20 Year(s) 60 Year(s) Male
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 02/05/2016 Mohamed Taher Maamouri ethics committee
Ethics Committee Address
Street address City Postal code Country
El Mrezgua Nabeul 8000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the morphine consumption In the 24 hours postoperatively
Secondary Outcome Visual Analog Scale 0-10 (VAS) pain score (while moving and at rest) 2 hours posoperatively. 6 hours posoperatively. 12 hours posoperatively. 24 hours posoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ICU Mohamed Taher Maamouri Hospital El Mrezgua Nabeul 8000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Taher Maamouri Hospital El Mrezgua Nabeul 8011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Taher Maamouri Hospital El Mrezgua Nabeul 8000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
ICU MTM Hospital El Mrezgua Nabeul 8000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charrada Hedi hedi1med@yahoo.fr +21622908288 Rue el eddrissi
City Postal code Country Position/Affiliation
DAR CHAABANE 8011 Tunisia Anaesthesia
Role Name Email Phone Street address
Principal Investigator Ben Ali Mechaal mechaal_benali@yahoo.fr +21698657034 AFH Mrezgua
City Postal code Country Position/Affiliation
Nabeul 8000 Tunisia Anaesthesia
Role Name Email Phone Street address
Principal Investigator Mili Iskander kingalexander85@yahoo.com +21697100389 El Mrezgua
City Postal code Country Position/Affiliation
Nabeul 8000 Tunisia Anaesthesia
Role Name Email Phone Street address
Public Enquiries Saidane Wassim wassim.saidane@gmail.com +21622934768 Building N°254 FLAT N°2 AIN ZAGhouane CITE EL WAHAT Diar SOUKRA
City Postal code Country Position/Affiliation
ARIANA 2036 Tunisia Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Souissi Hassen hassen.soui@gmail.com +21655948132 02 Street Sahel Monfleury
City Postal code Country Position/Affiliation
Tunis 1008 Tunisia Anesthesia
REPORTING
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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