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.: PACTR201604001549201 Date of Registration: 26/03/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A RANDOMISED CONTROLLED TRIAL INVESTIGATING THE EFFECT OF FENTANYL ON EPIDURAL VOLUME EXTENSION
Official scientific title A RANDOMISED CONTROLLED TRIAL INVESTIGATING THE EFFECT OF ADDING FENTANYL TO LOW DOSE BUPIVACAINE IN COMBINED SPINAL-EPIDURAL ANAESTHESIA, USING EPIDURAL VOLUME EXTENSION TECHNIQUE IN CESAREAN SECTION.
Brief summary describing the background and objectives of the trial Background: The technique of combined spinal-epidural anaesthesia for caesarean section has become increasingly popular in obstetric practice. Many users of the technique choose conventional intrathecal doses to achieve a reliable spinal block, and then use the epidural catheter to prolong anaesthesia and administer postoperative pain relief. However, the presence of a catheter in the epidural space allows the effect of the initial intrathecal injection to be manipulated before and during surgery. Various techniques have been developed to reduce spinal dose requirement by using the Epidural Volume Extension (EVE) technique. The epidural volume extension technique involves injecting an initial intrathecal dose of local anaesthetic and then injecting saline into the epidural space, which then extends the intrathecal block to a higher segment while utilizing the same intrathecal dose.(1) Lipophilic opioids are commonly used as additives in neuraxial anaesthesia for caesarean section. Fentanyl is one of the opioids commonly used. It is a short acting opioid that has been studied in spinal anaesthesia and has been found to enhance the quality of spinal anaesthesia.(2) Fentanyl however, has not been studied in Epidural Volume Extension technique. Different studies have been done on EVE and they have either used or omitted fentanyl yet they demonstrated an EVE effect with adequate anaesthesia. The results have been solely attributed to the EVE effect without taking into consideration the pharmacologic effect of fentanyl on the outcome. No study has been done to demonstrate the effect of fentanyl on the block characteristics and whether adding or omitting it makes a difference on the block. Objective: The study aims at determining the effect of fentanyl plus low dose bupivacaine on the spinal block level of combined spinal epidural (CSE) anaesthesia utilizing the Epidural Volume Extension technique.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2010
Actual trial start date 08/12/2010
Anticipated date of last follow up 28/02/2011
Actual Last follow-up date 31/03/2011
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
N/A N/A
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 By computer-generated random tables. Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fentanyl group 25mcg once 7.5mg of bupivacaine plus 25mcg of fentanyl intrathecally with 10mls of 0.9% physiological saline epidural injection. 22
Control Group No-fentanyl group 0mcg once 7.5mg of bupivacaine intrathecally with 10 mls of 0.9% physiological saline epidural injection. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All obstetric patients coming in for elective caesarean section in Aga Khan University Hospital Nairobi, who were; Patients willing to participate in the trial having completed a fully signed informed consent. American Society of Anesthesia class I or II patients. Emergency caesarean section patients ASA III and IV patients Patients with coagulation disorders Patient refusal 18 Year(s) 50 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 15/12/2010 Aga Khan University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the effect of fentanyl combined with low dose bupivacaine on the sensory block level after epidural volume extension. 5 minutes after CSE 2.5 minutes after EVE
Secondary Outcome To determine the effect of fentanyl combined with low dose bupivacaine on the motor block using the Modified Bromage score. After no change in sensory level
Secondary Outcome To determine the effect of fentanyl combined with low dose bupivacaine on analgesic efficacy by measuring the time to the first request for analgesia. First time patient used PCA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue Nairobi 30270-00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue Nairobi 30270-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Hospital 3rd Parklands Avenue Nairobi 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr. Thikra Sharif 3rd Parklands Avenue Nairobi 30270-00100 Kenya
Prof. Vitalis Mung'ayi 3rd Parklands Avenue Nairobi 30270-00100 Kenya
Dr. Dorothy Kamya 3rd Parklands Avenue Nairobi 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mudola Manyano salirado@yahoo.com +254722749167 Milimani
City Postal code Country Position/Affiliation
Kisumu 19631-40123 Kenya Program Director
Role Name Email Phone Street address
Public Enquiries Vitalis Mung'ayi salirado@yahoo.com +254724904010 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Consultant Anaesthesiologist
Role Name Email Phone Street address
Scientific Enquiries Mudola Manyano salirado@yahoo.com +254722749167 Milimani
City Postal code Country Position/Affiliation
Kisumu 19631-40123 Kenya Program Director
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