South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-102022-5278 Date of Approval: 31/10/2022
Trial Status: Approved
TRIAL DESCRIPTION
Public title A randomised controlled trial comparing Erector Spinae and Transversus Abdominis Plane blocks for postoperative analgesia after elective caesarean section
Official scientific title A randomised controlled trial comparing Erector Spinae and Transversus Abdominis Plane blocks for postoperative analgesia after elective caesarean section
Brief summary describing the background and objectives of the trial Adequate postoperative analgesia is essential to avoid negative sequelae for the infant and mother after caesarean section. However, inadequate analgesia is still frequently reported in patients after caesarean section. With an increasing rate of caesarean sections in South Africa, inadequate analgesia could result in a large burden of morbidity with public health implications. With respect to elective caesarean sections performed under neuraxial anaesthesia, various guidelines recommend the use of additional regional techniques such as fascial plane blocks as part of a multi-modal analgesic strategy. This is especially relevant when intrathecal morphine is not used in the spinal anaesthetic, which is the case in most caesarean sections performed in the South African public health sector. Aim: The aim of this study is to compare the postoperative analgesic efficacy of the Erector Spinae Plane block to the Transversus Abdominis Plane block in women undergoing elective caesarean section under spinal anaesthesia at the Rahima Moosa Mother and Child Hospital (RMMCH). Objectives: The primary objective of this study is: • To determine and compare total 24-hour morphine consumption between the two groups of patients receiving ESP or TAP blocks during elective caesarean section performed under spinal anaesthesia. The secondary objectives of this study are: • To describe and compare the time taken until first morphine patient-controlled analgesic (PCA) use in both groups. • To describe and compare the numeric rating scale pain scores at intervals 0-, 6-, and 24-hours in both groups. • To describe and compare opioid related side effects in both groups. • To describe and compare patient satisfaction at 24-hours in both groups. • To describe and compare the time taken to perform the blocks in both groups
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: Other
Anticipated trial start date 01/02/2023
Actual trial start date
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M220512 University of Witwatersrand Human research Ethics Committee - Medical
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector spinae plane block Single injection on each side of the back at end of surgery Single injection after surgery followed by post-operative analgesia, with follow up for 24 hours post-operatively Erector Spinae Plane block: An ultrasound guided regional nerve block technique whereby an echogenic needle is inserted into the potential space between the erector spinae plane muscle group and the transverse process of the vertebral body. Local anaesthetic is injected into this space, from where it spreads to the paravertebral space where it has the potential to block ventral and dorsal nerve roots thus providing somatic and visceral analgesia to the abdomen. This procedure will be performed on patients undergoing elective caesarean sections under spinal anaesthesia, in an effort to reduce postoperative pain and opioid consumption. 33
Control Group Transversus abdominis plane block Single injection on each side of the lower abdomen at the end of surgery Single injection after surgery followed by post-operative analgesia, with follow up for 24 hours post-operatively. Transverus abdominis plane block: An ultrasound guided regional nerve block technique whereby an echogenic needle is inserted into the potential plane between the internal oblique muscle and the transversus abdominis muscle of the abdominal wall . Local anaesthetic is injected into this space, from where it has the potential to block thoraco-abdominal nerves of the abdominal wall thus providing somatic analgesia to the abdomen. This procedure will be performed on patients undergoing elective caesarean sections under spinal anaesthesia, in an effort to reduce postoperative pain and opioid consumption. 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Elective caesarean section. • Adult patients ≥ 18 years of age. • ASA I - III. • Emergency Caesarean Section. • BMI ≥35 (Taken at time of consent). • Patients that do not give signed informed consent to participate. • Contra-indication to spinal anaesthesia. • Contra-indication to local anaesthetic agent or opioids. • Patients requiring conversion from spinal anaesthesia to general anaesthesia at any stage during the caesarean section. • Patients with any physical or mental impairment which prevents them from being able to use a patient-controlled analgesia (PCA) pump postoperatively. • Patients with pre-existing chronic pain syndromes. Adult: 19 Year(s)-105 Year(s) 18 Year(s) 50 Year(s) Female
APPROVALS
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 23/08/2022 University of Witwatersrand Human Research Ethics Committee. Medical
Ethics Committee Address
Street address City Postal code Country
Cnr York Road and 29 Princess of Wales Terrace, Parktown, 2193. Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine and compare total 24-hour morphine consumption between the two groups of patients receiving ESP or TAP blocks during elective caesarean section performed under spinal anaesthesia. 24 hours post-operatively
Secondary Outcome • To describe and compare the time taken until first morphine patient-controlled analgesic (PCA) use in both groups. • To describe and compare the numeric rating scale pain scores at intervals 0-, 6-, and 24-hours in both groups. • To describe and compare opioid related side effects in both groups. • To describe and compare patient satisfaction at 24-hours in both groups. • To describe and compare the time taken to perform the blocks in both groups 24 hours post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rahima Moosa Mother and Child Hospital Corner Fuel and Oudtshoorn street , Coronationville Johannesburg 2093 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Society of Anaesthesiologists PO Box 1935, Glenashley, 4022 South Africa Durban 4022 South Africa
Dr Aidan Eksteen 44 Stiglingh road johannesburg 2128 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Creatori Health Pty Ltd The Reserve, Unit 6, 4 Capricorn Way, Brackenfell, Cape Town, 7560 Cape town 7560 South Africa Medical equipment supplier
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aidan Eksteen eksteen.aidan@gmail.com +27849096177 7 York road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Registrar Anaesthesia
Role Name Email Phone Street address
Public Enquiries Aidan Eksteen eksteen.aidan@gmail.com +27849096177 7 York road,parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Registrar anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Janine Wagner drjaninewagner@gmail.com +27829337194 Corner Fuel and Oudtshoorn street, Coronationvilled
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Specialist Anaesthetist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained in this study will be made available to interested and qualified parties provided the data is applicable to the results obtained and has been de-identified. (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be made available from 3 months to 3 years after publication, with extensions viewed on a case-by-case basis Formal applications will be assessed on a qualification and quality of request basis and must include a clear aim that states the statistical analysis plan and data sharing agreement. These submissions will be reviewed by the principal investigator and supervisors and can be submitted to eksteen.aidan@gmail.com and drjaninewagner@gmail.com.
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
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 27/10/2022 Not previously stated M220512, University of Witwatersrand Human research Ethics Committee - Medical , 4784
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/10/2022 Not stated previously South African Society of Anaesthesiologists, PO Box 1935, Glenashley, 4022 South Africa, Durban, 4022, South Africa, Charities/Societies/Foundation, , R3740, Primary Funder
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/10/2022 Not previously stated Dr Aidan Eksteen, 44 Stiglingh road, johannesburg, 2128, South Africa, Self Funded, , R1000, Secondary Funder
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/10/2022 Not previously stated This funder is not providing money but is donating the consumables required Creatori Health, The Reserve, Unit 6, 4 Capricorn Way, Brackenfell, Cape Town, 7560, Cape Town, 7560, South Africa, Commercial Sector / Industry, , R5000, Primary Funder