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.: PACTR201711002793312 Date of Approval: 22/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TAP Block in Laparotomies.
Official scientific title Magnesium sulphate versus dexamethasone as an adjuvant to bupivacine for ultrasound guided transversus abdominis plane block in patients undergoing emergency laparotomies.
Brief summary describing the background and objectives of the trial After obtaining Institutional Ethical Committee approval and written informed consent, this prospective randomized double blind controlled study conducted on 90 adult patients aged 18-70 years, of American Society of Anesthesiologists (ASA) physical status I to III, scheduled for emergency laparotomies, ,under general anesthesia will be included in this study. According to the used medications, the patiants allocated into 3 groups (30 patients on each group). Group I (C group): received 40 ml bupivacine 0.25% (20 ml on each side ). Group II (D group): received 8 mg dexamethason (2ml) + 38 ml bupivacine 0.25% (20 ml on each side ). Group III (M group): received 200 mg magnesium sulphate (2 ml ) + 38 8 ml bupivacine 0.25% (20 ml on each side ). The studded medication prepared and supplied in similar syringe by an anesthetist not included in the management of the patient or data collection. Following placement of the standard monitors, induction of anesthesia, stabilizing the patient¿s hemodynamics, and before surgical incision, TAP block performed Parameters assessed: pre operative period: 1. Basal MAP,HR. Intra operative period: 1.BP,HR after induction and at 15,30,45,60,90 min after local anesthetic infilteration then every half an hour till end of surgery. 2. Total intraoperative fentanyl requirement post operative period: 1. Haemodynamic parameters including BP and HR at 1, 2,4,8,12,18,24hrs. 2.Visual analogue pain score at 1,2,4,8,12, 18,24hrs. 3. Onset and duration of analgesia. 4.Time of first analgesic request. 5.Total analgesic requirement over 1st 24 hrs. 6.side effect. 7.Time of discharge from postoperative anesthetic care unit we found that Adding dexamethasone or magnesium to bupivacaine produce lower VAPs, delayed the time of first analgesic request, decreased the total amount of postoperative analgesics and more hemodynamic stability in comparison to bupivacaine alone and magnesium sulfate was superior over dexamethasone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Emergency laparotomies,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 24/01/2017
Actual trial start date 21/02/2017
Anticipated date of last follow up 28/12/2017
Actual Last follow-up date 28/12/2017
Anticipated target sample size (number of participants) 95
Actual target sample size (number of participants) 90
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 Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site 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 TAP block 40 ml bupivacaine 0.25 % plus dexamethason (20) on each side - once For 1st 24 hrs sonar guided TAP block 30
Control Group TAP block 40 ml bupivacaine 0.25 % (20) on each side - once For 1st 24 hrs sonar guided TAP block 30 Active-Treatment of Control Group
Experimental Group TAP block 40 ml bupivacaine 0.25 % plus magnesium sulphate (20) on each side - once For 1st 24 hrs sonar guided TAP block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18_70. 2. Both gender. 3. Emergency laparotomies. 4. ASA I-III. 1. Drug allergy. 2. Opiod dependence. 3. Morbid obesity (BMI >40 kg/m2) . 4. Psychiatric disorder. 18 Year(s) 70 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 27/02/2017 Faculty of medicine -Minia university
Ethics Committee Address
Street address City Postal code Country
Cairo -Aswan agricultural road Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Cumulative intra operative and post operative analgesic requirement . 2. Time of first post operative analgesic request . 1- Intraoperative and 1st postoperative 24hrs 2- early postoperative hours
Secondary Outcome 1. Pain score during the first postoperatively 24 h. 2. Time of discharge of post anesthetic care unit. 3. Incidence of any side effect. 1.1st 24hrs 2. Hours or Days needed to stay in ICU 3. 1st 24hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medcine- Minia University Cairo-Aswan agricultural road Minia 61519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine -mina university Cairo -Aswan agricultural road Minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia university hospital El-horria street Minia 61519 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Huda ahmed Abd elazim El-Salam street Minia 61519 Egypt
Shadwa Rabea Mohamed Saad bin aby wakaas Minia 61519 Egypt
Omyma Shehata Mohamed El-horria street Minia 61519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Huda Abdelazim genior.huda@yahoo.com 01065483067 El-salam street
City Postal code Country Position/Affiliation
Minia 61519 Egypt Resident
Role Name Email Phone Street address
Public Enquiries Shadwa rabea Shadwa.rabea@yahoo.com 01004157778 Saad bin aby wakaas
City Postal code Country Position/Affiliation
Minia 61519 Egypt lecturer in anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Omyma shehata Omyma.shehata44@yahoo.com 01061762894 El-horria street
City Postal code Country Position/Affiliation
Minia 61519 Egypt Assistant professor in anesthesia
REPORTING
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