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.: PACTR202205836867776 Date of Registration: 31/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECTS OF HYPERBARIC AND ISOBARIC BUPIVACAINE ON POST SPINAL HEMODYNAMICS PROFILES AND BLOCK CHARACTERISTICS AMONG PARTURIENTS UNDERGOING ELECTIVE CESAREAN SECTION AT DILLA UNIVERSITY REFERRAL HOSPITAL: A RANDOMIZED CONTROLLED TRIAL STUDY
Official scientific title THE EFFECTS OF HYPERBARIC AND ISOBARIC BUPIVACAINE ON POST SPINAL HEMODYNAMICS PROFILES AND BLOCK CHARACTERISTICS AMONG PARTURIENTS UNDERGOING ELECTIVE CESAREAN SECTION
Brief summary describing the background and objectives of the trial Background: Cesarean section is an operative techniques by which fetus delivered through abdominal and uterine incision. The most commonly used anesthetic techniques for cesarean section is spinal anesthesia, which holds around 80%-90%. Bupivacaine is a well-known local anesthetic agent that can be available in isobaric and hyperbaric form. The differences within baricity of local anesthetic agents affect the hemodynamics profiles of parturient, onset, extent and duration of sensory and motor block. Hypotension is one of the most common post spinal complications during cesarean delivery that held around 80%-90%. Objective: To compare the effect of hyperbaric and isobaric bupivacaine on hemodynamics profile and block characteristics among parturient undergoing elective cesarean section under spinal anesthesia at Dilla University Referral Hospital, 2022.
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 10/06/2022
Actual trial start date 16/06/2022
Anticipated date of last follow up 10/08/2022
Actual Last follow-up date 30/08/2022
Anticipated target sample size (number of participants) 64
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Double Blind Randomized controlled Trial 70 days Isobaric bupivacaine will be supplied in 10ml and each ampoule contained in 5mg/ml solution (0.5%). 32 Active-Treatment of Control Group
Experimental Group Double Blind Randomized Controlled Trial 70 days Hyperbaric bupivacaine will be available in 4ml ampoule each ampoule contains 5mg/ml solution (0.5%) and 80mg dextrose (8%). 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parturient with single tone pregnancy ASA II Age range between 18-45 years BMI<35kg/m Multiple pregnancy Pregnant mothers with systemic disease, like renal impairment, chronic liver disease, uncontrolled diabetes mellitus, Pre-existing neurological disease, like paraplegia and multiple sclerosis Parturient with hypo or hyperthyroidism Gestational age <37 weeks Parturient with placenta abruption, placenta previa and preeclampsia Weight>85kg . Height<150cm,>170cm Any allergy to local anesthetic agents Adult: 19 Year-44 Year 18 Year(s) 45 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 08/02/2022 DURH IRB
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 13 Ethiopia
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 08/02/2022 The institutional review board of Dilla University College of health science and medicine
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 13 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Sensory block onset time  Motor block onset time  Duration of sensory and motor block 6 hours
Secondary Outcome  Incidence of hypotension 6 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral Hospital Dilla Dilla 13 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla 13 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla Ethiopia University
Primary Sponsor Dilla university Dilla Dilla 13 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Abebayehu Zemedkun Dilla Dilla Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aschalew Besha aschalewbesha5@gmail.com +251923295855 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University
Role Name Email Phone Street address
Public Enquiries Abebayehu Zemedkun abe.zemedkun@gmail.com +251900053426 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla university
Role Name Email Phone Street address
Scientific Enquiries Muhiddin Tadesses muhiddinhassen@gmail.com +251917860926 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide up on request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol With in twelve month Data collection, Analysis data, Ethical clearance
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