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.: PACTR202007634121137 Date of Approval: 30/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title magnesium sulphate for extending labor epidural analgesia for emergency cesarean section:
Official scientific title Anesthetic conversion of preexisting labor epidural analgesia for emergency cesarean section: Efficacy of levopubivacaine with or without magnesium sulphate. A prospective randomized study.
Brief summary describing the background and objectives of the trial Epidural analgesia is one of the most effective methods for providing adequate pain relief during labor. The epidural catheter can be used to extend the existing block to provide anesthesia for emergency cesarean section (CS). Magnesium has analgesic properties, primarily related to the regulation of calcium influx into cells and antagonism of N methyl D aspartate (NMDA) receptors in the central nervous system. In obstetric anesthesia, many studies have been examined the efficacy of magnesium sulfate (MgSO4) when added to spinal anesthesia, combined spinal and epidural anesthesia or epidural anesthesia. These studies have concluded that it improves the anesthetic and analgesic quality and reduce the consumption of postoperative analgesic requirements without additional side effects. This study hypothesized to evaluate the efficacy of adding magnesium sulfate to levobupivacaine for speeding the onset of extension of pre-existing labor epidural analgesia into adequate block to provide epidural anesthesia for emergency CS.
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: Drugs
Anticipated trial start date 01/08/2020
Actual trial start date
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 randomization using a randomization 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
Control Group group I epidural levopubivacaine once once patients will receive epidural 19.5 ml levobupivacaine 0.5%+0.5 ml normal saline 0.9% for extension of labor analgesia for emergency cesarean section 25 Active-Treatment of Control Group
Experimental Group group II epidural levopubivacaine with magnesium sulphate once once patients will receive 19.5 ml levobupivacaine 0.5% combined with 0.5 ml magnesium sulphate 10% (50mg) for extending labor analgesia for emergency cesarean section 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
parturients who were in active labor (gestational age>37 weeks) aged 18–35 years old, had an American Society of Anesthesiologists status II admitted for an emergency CS after an established labor epidural analgesia. an emergency CS of the first type multiple pregnancies a high-risk pregnancy (e.g. preeclampsia, antepartum hemorrhage, diabetes mellitus, body mass index (BMI) ≥35 kg/m2) a malfunctioning epidural catheter during the labor( no analgesia after two intra-partum top-up doses) last labor epidural supplementation of less than two hours, hemodynamic instability after a previous top-up documented history of allergy to any of the drugs used in the trial. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 Year(s) Female
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 06/07/2020 Research ethics committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
Elgeish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome onset of the block once
Secondary Outcome Duration of labor analgesia duration of labor epidural analgesia preoperative
Secondary Outcome Time since last top-up dose interval since last dose in epidural analgesia and epidural anesthesia
Secondary Outcome pre sensory and motor level and pain score sensory level, motor level, and pain score before injection for epidurala anesthesia
Secondary Outcome Time to block at level T6 interval from injection of epidural local anesthesia to reach sensory level at T6
Secondary Outcome Number of patients who needed top-up to reach level T6. number of patients who need extra local anesthetic dose to reach sensory level of T6
Secondary Outcome sensory and motor block at start of surgery sensory level and motor block after injection of epidural local anesthesia at the start of surgery
Secondary Outcome Number of patients needed Supplemental intraoperative analgesia extra doses of epidural local anesthesia needed intraoperative
Secondary Outcome duration of analgesia interval between injection of epidural local anesthesia to first request of analgesia postoperative by the patients
Secondary Outcome time to motor recovery interval between injection of epidural anesthesia to reach a Bromage score of 0 postoperative
Secondary Outcome Apgar score at 1 and 5 minutes after delivery of the baby
Secondary Outcome adverse events e.g. hypotension, bradycardia, somnolence for 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospita Elgeish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Tamer Mohamed Naguib Elgeish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Tamer Mohamed Naguib Elgeish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona El Mourad Elgeish Tanta 31527 Egypt
Radwa Fathy Mansour Elgeish Tanta 31527 Egypt
Mona Rafaat Elghamry Elgeish Tanta 31527 Egypt
Tamer Mohamed Naguib Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mansour rodywael@yahoo.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Tamer Naguib tnaguib1eg@yahoo.com 00201002937050 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Mona El ghamry drmonagh19802000@gmail.com 00201060101867 st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1-Demographic data 2-onset and duration of the block 3-time from skin incision to delivery 4-number of patients requiring supplemental analgesia Study Protocol 2 years to those who request the data via the email of the principal investigator according to the cause of the request
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