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.: PACTR201703002083424 Date of Approval: 08/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium sulphate as an adjuvant to levobupivacaine for post-operative analgesia in lower abdominal and pelvic surgeries under epidural anesthesia (R
Official scientific title Magnesium sulphate as an adjuvant to levobupivacaine for post-operative analgesia in lower abdominal and pelvic surgeries under epidural anesthesia (RCT)
Brief summary describing the background and objectives of the trial Epidural analgesia for postoperative pain management is considered a critical component of multimodal approach to achieve adequate analgesia with improved outcome. Levobupivacaine has a lower risk profile of toxicity regarding cardiovascular and central nervous systems than bupivacaine. Magnesium, as an adjuvant, has been used with local anesthetics for prolongation of postoperative epidural and intrathecal analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/08/2014
Actual trial start date 27/08/2014
Anticipated date of last follow up 01/09/2015
Actual Last follow-up date 27/10/2015
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL Magnesium sulphate as an adjuvant to levobupivacaine for post-operative analgesia in lower abdominal and pelvic surgeries under epidural anesthesia (RCT)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group adding magnisium sulfate to epidural levobupivacaine 14 ml levobupivacaine 0.5% with 0.5 ml magnesium sulphate 10% (50 mg) in 0.05 ml normal saline 0.9 NaCl till end of surgery adding magnisium sulfate to epidural levobupivacaine 50
Control Group control group patients received 15 ml of ( 14ml levobupivacaine 0.5% plus 1 ml normal saline 0.9 NaCl ) at induction then continuous infusion by 5 ml /hour till the end of the surgery. till end of surgery adding 1 ml of normal saline to 14 ml of levobupivacaine 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Age between 20-60 year old -Classified by the American Society of Anesthesiologist (ASA) physical status as class I or class II. -Lower abdominal & pelvic surgeries -Patient¿s refusal. -History of allergic reactions to local anesthetics. -Coagulopathy. -Severe cardiac, respiratory, hepatic or renal disease 20 Year(s) 60 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 06/07/2014 departmental etical commitee of anesthesi , surgical ICU & pain department, faculty of medicine, Cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr El-eni street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time of first rescue analgesia time from discontinuation of epidural anaethesia till the first use of rescue analgesia
Secondary Outcome intraoperative hemodynamics during intraoperative period
Secondary Outcome onset of epidural block (sensory & motor) intraoperatively, from the end of injection to complete sensory & motor block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kasr El-Eini hosopital kasr El-Eni street Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, Cairo university Kasr El-ENi street Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine, Cairo university Kasr el-Eni street CAiro 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Heba Omar Hadaek El-Ahram Giza 12572 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Omar hebaomar2@yahoo.com +2-01128102222 Hadaek El-Ahram
City Postal code Country Position/Affiliation
Giza Egypt lecturer at anesthesia, surgical ICU & pain department, faculty of medicine, Cairo university
Role Name Email Phone Street address
Public Enquiries Heba Omar hebaomar2@yahoo.com +2-01128102222 Hadaek ElAhram
City Postal code Country Position/Affiliation
Giza 12572 Egypt lecturer at anesthesia, surgical ICU & pain department, faculty of medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Heba Omar Hebaomar2@yahoo.com +2-01128102222 Hadaek ElAhram
City Postal code Country Position/Affiliation
Giza 12572 Egypt lecturer at anesthesia, surgical ICU & pain department, faculty of medicine, Cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information