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.: PACTR202301645957324 Date of Approval: 17/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Introduction and Justification Adequate postoperative analgesia is essential to avoid negative sequelae for the infant and mother after a caesarean section. However, inadequate analgesia is still frequently reported in patients after caesarean sections. With respect to elective caesarean sections performed under neuraxial anaesthesia, various guidelines recommend the use of additional fascial plane blocks such as the Transversus Abdominis Plane (TAP) block or Erector Spinae Plane (ESP) block 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. While some studies have shown that the ESP block may provide superior outcomes to the TAP block for post caesarean section analgesia, no published data currently exists to support this in the South African setting. Aims To compare the postoperative analgesia efficacy of ESP blocks to TAP blocks in women undergoing elective caesarean section under spinal anaesthesia at 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.
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2023
Actual trial start date 09/01/2023
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 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
Control Group Transversus abdominis plane group Single shot, bilateral ultrasound guided Transversus abdominis plane blocks with use of Bupivacaine with adrenaline diluted to 0.25% with 20 milliliters injected each side(total volume 40 mls per patient) , followed by post-operative analgesia with a morphine PCA pump and with follow up for 24 hours post-operatively Single shot, bilateral injection monitored over 24 hours 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
Experimental Group Erector Spinae Plane Block A single shot, bilateral, ultrasound guided erector spinae plane block with the use of bupivacaine with adrenaline diluted to 0.25%, with 20millilitres injected bilaterally( Total volume 40mls per patient) followed by post-operative analgesia with a morphine PCA pump and with follow up for 24 hours post-operatively Single shot, bilateral injections followed up for 24 hours 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
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-44 Year 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 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
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 0, 6 and 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rahima Moosa Mother and Child Hospital Corner Fuel road and Oudtshoorn street, Coronationville johannesburg 2112 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Society of Anaesthesiologists P.O. Box 22511 Glenashley durban 4022 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Creatori Health The Reserve, Unit 6, 4 Capricorn Way, Brackenfell, Cape Town, 7560 cape town 7560 South Africa Commercial Sector/Industry
Secondary Sponsor Gabler medical 22-24 Thor Circle, Viking Place, Cape Town, 7460, South Africa cape town 7460 South Africa Commercial Sector/Industry
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 44 stiglingh road, edenburg
City Postal code Country Position/Affiliation
johannesburg 2128 South Africa University of Witwatersrand Anaesthesiology
Role Name Email Phone Street address
Public Enquiries Aidan Eksteen eksteen.aidan@gmail.com +27849096177 44 stiglingh road, edenburg
City Postal code Country Position/Affiliation
johannesburg 2128 South Africa University of Witwatersrand Anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries Aidan Eksteen eksteen.aidan@gmail.com +27849096177 44 stiglingh road
City Postal code Country Position/Affiliation
johannesburg 2128 South Africa University of Witwatersrand Anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries Janine Wagner drjaninewagner@gmail.com +27829337194 Corner fuel road and oudtshoorn road, coronationville
City Postal code Country Position/Affiliation
johannesburh 2112 South Africa University of Witwatersrand Anaesthesiology
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information