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.: PACTR202001547280753 Date of Registration: 27/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Unilateral TAPB vs caudal analgesia in lower abdominal surgeries in children
Official scientific title Postoperative analgesic efficacy of epsilateral ultrasound guided transversus abdominis plane block versus caudal epidural block using levobupivacaine in lower abdominal surgeries in children
Brief summary describing the background and objectives of the trial Patients were randomly allocated into two equal groups to receive either ipsilateral ultrasound guided TAP block using levobupivacaine (n= 16) or caudal block using levobupivacaine (n =16). The randomization sequence was concealed in opaque closed envelops that were sequential numbered, which were opened on the day of surgery after patient assignment to study. Group TAP: received ipsilateral ultrasound guided TAP block with 0.5 ml /kg of 0.25 % levobupivacaine. Group Caudal: received blind caudal block with 0.5ml/kg of 0.25% levobupivacaine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2016
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/11/2018
Actual Last follow-up date 01/12/2018
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 32
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Research 2598 Suez canaluniversity, faculty of medicine, research ethics committee
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Epsilateral Ultrasound guided transversus abdominis plane block 0.5ml/kg levobupivacaine 0.25% Once 1) The ultrasound transducer placed in midline over the rectus abdominis muscle and traced laterally to the region above the iliac crest to the lumbar triangle of Petit (bounded by the latissimus dorsi muscle posteriorly, the external oblique muscle anteriorly, and the iliac crest inferiorly) where the probe placed horizontally across the abdomen in the mid axillary line between the lower costal margin and iliac crest as the 3 muscle layers can be seen running parallel to one another. 2) A 22 gauge, 2.5 inch echogenic short beveled block needle was inserted utilizing the ‘in-plane’ technique from the medial aspect of the probe between the internal oblique and the transversus abdominis muscles. Then levobupivacaine slowly injected. If the needle was correctly positioned, the fascial plane was seen to separate and form a well-defined, hypoechoic, elliptical shape between the internal oblique and transversus abdominis muscles. 3) After confirming correct placement of needle attached with flexible tubing to a syringe filled with the study solution, 0.5ml/kg of 0.25% levobupivacaine was injected in the space. 16
Control Group Caudal epidural block 0.5ml/kg levobupivacaine 0.25% Once 1- A left lateral position was obtained with both hips flexed 900. 2- Sacral hiatus felt as a groove above coccyx and between two bony prominences, the sacral cornuae. 3- A 23 gauge needle was advanced at a 450 angle cephalad until a pop is felt as the needle pierces the sacrococcygeal membrane. 4- Angle of the needle was flattened and advanced. 5- Aspiration for blood and CSF performed, and if negative, injection of 0.5 ml /kg of levobupivacaine 0.25% ( prepared by diluting levobupivacaine 0.5% with normal saline in ratio of 1:1) as single dose. 16 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 1-5 years old. 2. Gender: both male and female. 3. AMerican Society of Anesthesiologists physical status classification I & II 4. Patients scheduled to undergo elective operations with unilateral infra-umbilical incision. 1. Patients who had infection or skin lesion (angioma, hair tuft or nevus) at the site of puncture for local anesthetic injection. 2. Evidence of peritonitis or septicemia. 3. Patients who had bleeding disorders. 4. History of allergy to local anesthetics. 5. Patient received preoperative analgesics. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 5 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 20/01/2016 Suez canal university faculty of medicine. Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Ring road, Ismailia, Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare efficacy of ultrasound guided TAP block to that of caudal block in lower abdominal surgeries in children regarding time of first request of analgesia in minutes. Time of first request of analgesia posoperative
Secondary Outcome • To measure postoperative pain using FLACC score. • To compare efficacy of ultrasound guided TAP block versus caudal block in lower abdominal surgeries among children in relieving postoperative pain measured by 24 hours analgesic consumption. • To detect hemodynamic changes (heart rate, respiratory rate, blood pressure) in both groups. • To measure parent satisfaction in both groups. • To measure surgeon satisfaction in both groups. To assess quality of analgesia in both groups
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez canal university hospital Ring road, imailia, Egypt Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Teema Ring road Ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eman Mohamed Abdel Haleem Teema Ring road Ismailia Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El lilly 10, gamaa kadeema Ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Teema Dr_emamteema@med.suez.edu.eg +201009311714 Street 8, suez canal authority maashat buildings
City Postal code Country Position/Affiliation
Ismailia Egypt Lecturer of Anesthesia faculty of medicine Suez canal University
Role Name Email Phone Street address
Scientific Enquiries Ahmed El lilly ahmed.lilly@gmail.com +201129111066 Street 10, el gamaa el kadeema
City Postal code Country Position/Affiliation
Ismaiia Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Mohamed Emad Abdel ghaffar omda_eg@hotmail.com +201003179831 Suez Canal University, faculty of medicine, anesthesia department
City Postal code Country Position/Affiliation
Ismailia Egypt Professor and dean of anesthesia depatment
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication Informed Consent Form,Statistical Analysis Plan,Study Protocol Study protocol and informed consent were prepared. Statistical analysis plan will be available soon Can be uploaded.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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