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.: PACTR202001800912516 Date of Approval: 07/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-assisted versus landmark-based spinal block performance in emergency caesarean delivery in obese patients at a central hospital
Official scientific title Ultrasound-assisted versus landmark-based spinal block performance in emergency caesarean delivery in obese patients at a central hospital
Brief summary describing the background and objectives of the trial Introduction and Justification: Obstetric anaesthesia-associated mortality and morbidity has decreased dramatically over the past several decades. Complications of general anaesthesia remain a significant cause of maternal mortality, particularly in South Africa. Neuraxial anaesthesia would be a more appropriate technique in many of these cases. Difficult spinal anatomy is associated with obesity in pregnancy. Preprocedural ultrasound may assist in these cases. It has been shown to improve spinal block performance, decrease the number of attempts and reduce procedural time in this subpopulation. Aims: The aim of this study is to assess the effect of the ultrasound-assisted technique on the technical performance of spinal blockade by anaesthetists in emergency caesarean deliveries in obese patients at a central hospital, as compared to the standard landmark-based technique. The primary objectives of this study are to: • to describe and compare the first-pass success rate • to describe and compare the number of needle punctures • to describe and compare the number of needle passes • to describe and compare the procedure time in the ultrasound-assisted and landmark-based groups. The secondary objectives of this study are to: • describe the initial intervertebral space used, number of intervertebral spaces attempted and final intervertebral space used during spinal block in each group • describe the clinical assessment of factors associated with difficult spinal block in each group • compare patient factors (presence/absence of factors associated with difficult spinal block) with technical measures of spinal block performance • compare the measured ultrasound distance (UD) to the actual needle depth (ND).
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 Ultrasound Assisted Spinal Anaesthetic
Anticipated trial start date 02/12/2019
Actual trial start date 03/01/2020
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date 24/02/2020
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 43
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Assisted Spinal Anaesthetic N/A N/A Ultrasound is used to delineate spinal anatomy prior to spinal anaesthetic procedure. Marker used to indicate anatomy. Spinal anaesthetic administered using marks from pre-procedural ultrasound to direct spinal needle insertion site, depth and angle. 19
Control Group Landmark Based Spinal Anaesthetic N/A N/A Use of standard landmark-palpation based technique for determining insertion site of spinal needle. 19 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The patient inclusion criteria for this study are: • ASA I, II and III patients • age  18 years • presenting for emergency caesarean delivery • who consent to take part in the study • BMI at first antenatal weight recording  30kg.m-2 • under spinal block as the first choice of anaesthetic • by an anaesthetist who meets study criteria. The anaesthetist inclusion criteria for this study are: • qualified doctor working in the Department of Anaesthesiology • medical officer or registrar • with at least two years of supervised experience in anaesthesia • who consents to inclusion to the study. The patient exclusion criteria in this study are: • patients with contraindications to spinal block, including known spinal disease • patient unable to communicate in English. The anaesthetist exclusion criteria for this study are • prior inclusion in the study two times. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 08/11/2019 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, University of the Witwatersrand, Phillip V Tobias Health Sciences Building, 29 Princess of Wales Terrace, Parktown, Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome First-pass success rate - rate at which subarachnoid space is reached on first puncture and pass of spinal needle During spinal anaesthetic administration
Primary Outcome Number of needle punctures - the number of times the spinal needle was withdrawn from the skin and reinserted. During spinal anaesthetic administration
Primary Outcome Number of needle passes - the number of times the spinal needle is advanced, withdrawn and then redirected towards the subarachnoid space without exiting the skin. During spinal anaesthetic administration
Primary Outcome Procedure time - the time from first insertion of the spinal needle through the skin to connecting the syringe for injection after free cerebrospinal fluid flow is noted During spinal anaesthetic administration
Secondary Outcome Initial intervertebral space used - the intervertebral space entered with the first needle puncture During spinal anaesthetic administration
Secondary Outcome Final intervertebral space - the intervertebral space entered with the needle puncture resulting in successful cerebrospinal fluid flow During spinal anaesthetic administration
Secondary Outcome Number of intervertebral spaces attempted - number of different intervertebral spaces entered during spinal anaesthetic administration During spinal anaesthetic administration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Rd, Diepkloof Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bojan Korda 31 Cedarwood, 1076 Cornelius Street, Weltevredenpark Johannesburg 1709 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bojan Korda 31 Cedarwood Road, 1076 Cornelius Street, Weltevredenpark Johannesburg 1709 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dorinka Nel 26 Chris Hani Rd, Diepkloof Johannesburh 1864 South Africa
Juan Scribante 7 York Rd, Parktown Johannesburg 2193 South Africa
Helen Perrie 7 York Rd, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Bojan Korda drbkorda@gmail.com +27782283474 31 Cedarwood, 1076 Cornelius Street, Weltevredenpark
City Postal code Country Position/Affiliation
Johannesburg 1709 South Africa Registrar Anaesthesiology
Role Name Email Phone Street address
Principal Investigator Bojan Korda drbkorda@gmail.com +27782283474 31 Cedarwood, 1076 Cornelius Street, Weltevredenpark
City Postal code Country Position/Affiliation
Johannesburg 1709 South Africa Registrar Anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries Bojan Korda drbkorda@gmail.com +27782283474 31 Cedarwood, 1076 Cornelius Street, Weltevredenpark
City Postal code Country Position/Affiliation
Johannesburh 1709 South Africa Registrar Anaesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified data collection sheet data using study numbers to represent individual patients. Study Protocol Within 12 months of study completion Upon request and motivation to drbkorda@gmail.com (principal investigator).
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