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.: PACTR201612001905316 Date of Approval: 03/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of adding midazolam to bupivacaine during ultrasound guided single injection rectus sheath block.
Official scientific title Effect of adding midazolam to bupivacaine during ultrasound guided single injection rectus sheath block. A randomized controlled trial
Brief summary describing the background and objectives of the trial Various adjuvants have been tried to improve quality and increase duration of local anesthetics during various nerve blocks. We aimed to evaluate the effect of adding midazolam to bupivacaine on rectus sheath (RS) block
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 12/12/2016
Actual trial start date 12/12/2016
Anticipated date of last follow up 07/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 Simple randomisation using a radomisation table created by a computer software program 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 midazolam group get RS block using 20 ml of bupivacaine hydrochloride 0.25% + midazolam 50µg/kg in 2 ml saline 0.9% get RS block using 20 ml of bupivacaine hydrochloride 0.25% + midazolam 50µg/kg in 2 ml saline 0.9% 30
Control Group control group 20 ml of bupivacaine hydrochloride 0.25% + 2 ml saline 20 ml of bupivacaine hydrochloride 0.25% + 2 ml saline 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients ASA I or II undergoing umbilical hernia repair refusal of the patients to give informed consent, pre-existing coagulation disorders (international normalized ratio > 1.5), morbid obesity (body mass index ¿ 35 kg/m2), significant cardiac, hepatic or renal disease, local infection at the site of the block or allergy to the drug under study 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 28/11/2016 Ethical committee of Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st. Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative 48 h morphine consumption postoperative 48h
Secondary Outcome duration of analgesia, postoperative pain, as evaluated by VAS for pain scoring at 1, 2,6, 12, 24, and 48 h postoperatively, reported nausea, vomiting, somnolence or any adverse drug reactions like pruritus, and bowel activity postoperative 48 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
Khaled M Mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
Zeinab Abdel-Aziz Kasemy 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
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