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.: PACTR201510001306226 Date of Registration: 14/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transversus abdominis plane block versus local anesthetic wound infiltration
Official scientific title Transversus abdominis plane block versus local anesthetic wound infiltration in patients undergoing open inguinal hernia repair surgery
Brief summary describing the background and objectives of the trial The transversus abdominis plane (TAP) block has been shown to be a safe and effective postoperative adjunct analgesia method in a variety of surgical procedures and it is suggested as part of the multimodal anesthetic approach to enhance recovery after lower abdominal surgeries This study aimed to compare the analgesic effect of ultrasound-guided TAP block versus wound infiltration in patients undergoing open 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,Digestive System,Post operative analgesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/03/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 14/05/2015
Actual Last follow-up date 13/05/2015
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 63
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 computer-generated sequence of random numbers Sealed opaque envelopes 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 Group W Wound infiltration with 0.2¿ml/¿kg 0.25% levobupivacaine at the site of incision after induction of general anaesthesia and before start of surgical procedure. 30
Experimental Group Group T Ultrasound guidance TAP block with 0.25% levobupivacaine 0.5¿ml/¿kg was performed on the same side as the hernia after induction of general anaesthesia and before start of surgical procedure 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 male patients, ASA I and II, scheduled for open unilateral inguinal hernia repair under general anaesthesia were inability to consent to the study, skin infection at the puncture site, chest diseases, hepatic, renal or coagulation disorders, contra-indication to any of the drugs used during the study. 18 Year(s) 65 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
Yes 01/04/2014 Benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Farid Nada st. Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total morphine requirement over 24 hours
Secondary Outcome Time to first analgesic request time from patient's arrival to PACU till VAS > 4
Secondary Outcome number of patients requiring analgesia Over 24 hours
Secondary Outcome visual analogue pain score at rest and during cough at 2,4,8,12,24 hours were assessed over the course of 24¿hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha University Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Authors Farid Nada st.- Faculty of medicine- Anesthesia department Benha 230280 Egypt Hospital
Primary Sponsor Benha university Farid Nada st. Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Anesthesia department Benha faculty of medicine- Farid Nada st. Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com 00201005204130 20 Ezz Eldin Omar st
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Ehab Elshahhat Afifi elshahat_e@yahoo.com 00201223481232 Mansheit Elnoor st.
City Postal code Country Position/Affiliation
Benha 231211 Egypt Assistant professor of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com 00201223142889 Oman st. - Eldokki
City Postal code Country Position/Affiliation
Giza 12999 Egypt Professor of anesthesia and ICU
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