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.: PACTR201505001103180 Date of Approval: 16/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound Guided Rectus Sheath Block for Pediatric Patients undergoing Abdominal Midline Operations: A randomized controlled trial.
Official scientific title Sixty patients of both sexes between 2 and 10 years old, ASA I ¿ II physical status, undergoing midline abdominal procedures are involved in this randomized controlled trial. Patients were randomly allocated into one of two groups (thirty patients each) ; group R (RSB group) and group C (control group). Both groups received general anesthesia . Group R received bilateral rectus sheath block with 0
Brief summary describing the background and objectives of the trial Under high resolution of ultrasonic guidance, bilateral rectus sheath block (RSB) can be performed with higher success rate and fewer complications by injecting the local anesthetic solution between the rectus abdominus muscle and its posterior sheath. This results in blocking the anterior branches of lower thoracic spinal nerves supplying central portion of anterior abdominal wall. The effectiveness of this procedure was proved by a decrease in the intraoperative and postoperative analgesic requirements. Bilateral rectus sheath block (RSB) under ultrasound guidance provide effective intraoperative and postoperative analgesia with more stable hemodynamics for pediatric patients undergoing elective midline abdominal procedures.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 19/04/2015
Actual trial start date 20/04/2015
Anticipated date of last follow up 15/07/2015
Actual Last follow-up date 15/07/2015
Anticipated target sample size (number of participants) 70
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
Parallel: different groups receive different interventions at same time during study Randomised sealed opaque envelops by computer generated tables. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group C Fentanyl 1µg/kg only. single dose fentanyl during induction of anesthesia. Induction of general anesthesia was done in both groups using propofol 2.5mg/kg, fentanyl 1µg/kg, atracurium 0.5mg/kg and the trachea was intubated. Maintenance of anesthesia was done using isoflurane 1 MAC in oxygen and air with maintenance dose of atracurium 0.1mg/kg. 30 Active-Treatment of Control Group
Experimental Group Group R Fentanyl 1µg/kg during induction followed by ultrasound guided bilateral rectus sheath block with 0.5 ml/kg bupivacaine 0.25% after intubation. Induction of general anesthesia was done in both groups using propofol 2.5mg/kg, fentanyl 1µg/kg, atracurium 0.5mg/kg and the trachea was intubated. Maintenance of anesthesia was done using isoflurane 1 MAC in oxygen and air with maintenance dose of atracurium 0.1mg/kg. after intubation,ultrasound guided bilateral rectus sheath block with 0.5 ml/kg bupivacaine 0.25% was done. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sexes, ASA I ¿ II physical status, scheduled for elective abdominal midline operation. Patients with hepatic disease, bleeding or neurological disorders, known hypersensitivity to local anesthetics, evidence of peritonitis, sepsis, or infection at the site of needle insertion and those who require emergency operations were excluded from the study. 2 Year(s) 10 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 05/03/2015 local ethical committee of faculty of medicine, Ain shams university.
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbasia district. cairo PO Box:11539 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was degree of pain according to Objective Bahavioral Pain scale. immediately postoperatively and then at 4, 12 and 24 hours.
Secondary Outcome secondary outcome measures were hemodynamic parameters, intraoperative fentanyl requirement and postoperative need for analgesia. - hemodynamic parameters (measured at baseline before induction of general anesthesia, 5 minutes after induction of general anesthesia in group C and after the RSB in group R, then every 10 minutes till end of surgery) - intraoperative fentanyl requirement at end of surgery. - analgesic dose in the first 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine, Ain Shams university. Ramsis street, Abbasia district. cairo PO Box:11539 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams university Ramsis street, Abbasia district cairo PO Box: 11539 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university Ramsis street, Abbasia district. cairo PO Box: 11539 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Houssein 5 Abdelazem Salama street, of Makram Ebed street, Nasr City. cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour mostafa.mansor@med.asu.edu.eg +201093322145 5 Abdelazem Salama street, of Makram Ebed street, Nasr City.
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg +201093322145 5 Abdelazem Salama street, of Makram Ebed street, Nasr City.
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour mostafa.mansor@med.asu.edu.eg +201093322145 5 Abdelazem Salama street, of Makram Ebed street, Nasr City.
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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