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.: PACTR201804003261749 Date of Approval: 28/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Epidural painless labor
Official scientific title Effect of tramadol as a local anesthetic adjuvant in epidural labour analgesia: Randomized controlled study
Brief summary describing the background and objectives of the trial Pain and agony during childbirth are quite unbearable and sometimes beyond description. The pain if not adequately controlled may affect respiratory, cardiovascular, gastrointestinal, urinary and neuroendocrine functions. Pain also reduces uteroplacental blood flow leading to altered fetal homeostasis. Effective analgesia during labor will prevent these avoidable consequences. According to guidelines of the American Society of Anesthesiology (ASA), and American College of Obstetrics and Gynecology (ACOG), epidural analgesia is recommended in painless labor as the most flexible, effective, and least depressing to the central nervous system of the choices available. Women also may ask for alternatives to central neuraxial analgesia. Current practice in obstetric analgesia is to combine local anesthetics with adjuvant drugs in order to maintain high efficacy and comfort while reducing individual drug doses and side effects. Tramadol, a synthetic 4-phenylpiperidine analog of codeine, is a racemic mixture of two enantiomers, with synergistic anti-nociceptive interaction.The result is an opioid with a lack of respiratory depressant effects despite an analgesic potency that has been shown to be approximately equal to that of pethidine in some studies. The aim of this study is to evaluate the effect of the use of tramadol as an adjuvant to local anesthetics in epidural analgesia for female patients presented for normal vaginal delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Labor analgesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/02/2018
Actual trial start date 27/02/2018
Anticipated date of last follow up 26/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 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 Control group Patients in this group will receive epidural bupivacaine at a volume of 10 ml and concentration of 0.25% as induction of analgesia. The block was continued by epidural bupivacaine 0.125% at a volume o Till the end of the labor Epidural bupivacaine 30 Active-Treatment of Control Group
Experimental Group Tramadol group Patients in this group will receive epidural bupivacaine 0.25 % at a volume of 10 ml containing tramadol 5 mg/ml as induction of analgesia. The block was continued by epidural bupivacaine 0.125% at a Tilld elivery of the fetus Epidural bupivacaine and tramadol 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Pregnant female patients -Aged from 21 to 30 years old -With more than 37 weeks of gestation -Vertex presentation -Active normal labor -Cervical dilatation more than 3 cm. -Refuse local anesthesia -Hemodynamically unstable -Known or suspected allergy to the used drugs -With obstetric disorders -Pregnancy-induced hypertension -Suspected or documented coagulopathy -Body mass index more than 35 kg/m2 21 Year(s) 30 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 18/02/2018 Research Ethics Committee of Tanta University, Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
1, Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Onset of sensory block After initiation of the loading dose of the local anesthetic mixture.
Secondary Outcome Motor block - Before epidural analgesia - Every 15 min in the first hour of epidural analgesia -Every 30 min after the first hour.
Secondary Outcome Sedation score - Before epidural analgesia - Every 15 min in the first hour - Every 30 min after the first hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Tanta University 1, Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 1, Algeish st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Tanta University 1, Algeish st Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elsayed Afandy Alnady st Tanta 31511 Egypt
Dr. Radwa Fathey Mansour Elnady st Tanta Algharbia Governate 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@gmail.com 00201002977048 Saied st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Fatheya Khalil Fatheya.khalil@magrabi.com 00201225123291 Botros st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Head of medical service, Magraby eye hospital
Role Name Email Phone Street address
Scientific Enquiries Salah Elsherif salahalsherif505@yahoo.com 00201020150330 Ibn Alfared st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of anesthesia and surgical intensive care
REPORTING
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