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.: PACTR202212811501503 Date of Approval: 01/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Transversus Abdominis Plane Block with Dexamethasone and Bupivacaine on Pain Relief Following Caesarean Delivery
Official scientific title Effect of Perineural Dexamethasone on Ultrasound-Guided Transversus Abdominis Plane Block For Post Caesarean Analgesia At Korle-Bu Teaching Hospital
Brief summary describing the background and objectives of the trial Caesarean delivery (CD) is a common surgical procedure with associated significant post-operative pain. Adequate post-caesarean analgesia enables the new mother to take care of the newborn while preventing the debilitating effects of uncontrolled post-operative pain. The most frequent negative response to caesarean delivery in Ghanaian women is pain. Analgesic options following CD in Korle-Bu Teaching Hospital include the use of intrathecal opioids (fentanyl), parenteral opioids (intramuscular pethidine), intravenous paracetamol and rectal diclofenac. The addition of the bilateral transversus abdominis plane (TAP) block with dexamethasone as an adjunct to the existing pain management modalities will provide adequate post-caesarean delivery analgesia and improve patient satisfaction. AIM The aim of this study is to assess the safety and effect on the duration of postoperative analgesia of perineural dexamethasone in ultrasound-guided bilateral TAP block in parturients who undergo caesarean delivery under spinal anaesthesia at Korle-Bu Teaching Hospital.
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 Bilateral transversus abdominis plane block with saline, bupivacaine and dexamethasone
Anticipated trial start date 01/03/2021
Actual trial start date 31/05/2021
Anticipated date of last follow up 30/07/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 99
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bilateral transversus abdominis plane block using normal saline 20ml bilaterally (Total 40ml) Single shot bilateral TAP block to be performed immediately following caesarean delivery Ultrasound-guided bilateral TAP block using the Butterfly iQ® Ultrasound-on-ChipTM (Butterfly Network Inc. USA) portable ultrasound probe paired with a Samsung® Galaxy S10+ Android® mobile phone. The lateral approach to the TAP block will be performed with the patient in the supine position by placing the ultrasound probe in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles are identified as well as the fascial plane between the internal oblique and the transversus abdominis muscles. The needle is inserted in the anterior axillary line, in-plane and directly under the ultrasound probe. The needle tip is advanced until it reaches the fascial plane between the internal oblique and transversus abdominis muscles in the midaxillary line. On negative aspiration of blood, the normal saline will be delivered in aliquots of 5ml with regular aspiration between aliquots until the total amount of block normal saline is administered. This will be performed with real-time monitoring of injectate spread which appears as a hypoechoic expansion of the TAP under ultrasound guidance. The TAP block will then be performed on the opposite side, using the same technique and the same injectate. 33 Placebo
Experimental Group Bilateral transversus abdominis plane block using plain bupivacaine 20ml of 0.25% plain bupivacaine bilaterally (Total 40ml) Single-shot bilateral TAP block immediately following caesarean delivery ultrasound-guided bilateral TAP block using the Butterfly iQ® Ultrasound-on-ChipTM (Butterfly Network Inc. USA) portable ultrasound probe56 paired with a Samsung® Galaxy S10+ Android® mobile phone. The lateral approach to the TAP block will be performed with the patient in the supine position by placing the ultrasound probe in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles are identified as well as the fascial plane between the internal oblique and the transversus abdominis muscles. The needle is inserted in the anterior axillary line, in-plane and directly under the ultrasound probe. The needle tip is advanced until it reaches the fascial plane between the internal oblique and transversus abdominis muscles in the midaxillary line. On negative aspiration of blood, the 20ml 0.25% plain bupivacaine will be delivered in aliquots of 5ml with regular aspiration between aliquots until the total amount of plain bupivacaine is administered. This will be performed with real-time monitoring of injectate spread which appears as a hypoechoic expansion of the TAP under ultrasound guidance. The TAP block will then be performed on the opposite side, using the same technique and the same injectate. 33
Experimental Group Bilateral transversus abdominis plane block using plain bupivacaine and dexamethasone 20ml of 0.25% plain bupivacaine + 4mg dexamethasone bilaterally (Total 40ml 0.25% plain bupivacaine + 8mg dexamethasone) Single-shot bilateral TAP block to be performed immediately following caesarean delivery ultrasound-guided bilateral TAP block using the Butterfly iQ® Ultrasound-on-ChipTM (Butterfly Network Inc. USA) portable ultrasound probe56 paired with a Samsung® Galaxy S10+ Android® mobile phone. The lateral approach to the TAP block will be performed with the patient in the supine position by placing the ultrasound probe in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles are identified as well as the fascial plane between the internal oblique and the transversus abdominis muscles. The needle is inserted in the anterior axillary line, in-plane and directly under the ultrasound probe. The needle tip is advanced until it reaches the fascial plane between the internal oblique and transversus abdominis muscles in the midaxillary line. On negative aspiration of blood, the injectate containing 20ml (0.25% plain bupivacaine + 4mg dexamethasone) will be delivered in aliquots of 5ml with regular aspiration between aliquots until the total amount of block injectate is administered. This will be performed with real-time monitoring of injectate spread which appears as a hypoechoic expansion of the TAP under ultrasound guidance. The TAP block will then be performed on the opposite side, using the same technique and the same injectate. 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 2 pregnant women at term presenting for elective caesarean section Patient refusal Incisions other than Pfannenstiel Documented adverse reactions to local anaesthetics or glucocorticoids Pregnant women with diabetes mellitus Pregnant women with cardiovascular disease Body weight <60kg (so as not to exceed the maximum safe dose) Body mass index >35kg/m2 Presence of foetal pathology Presence of coagulation disorders Premedication with opioid or non-opioid analgesics, corticosteroids or NSAIDs Patients in whom NSAIDs are contraindicated History of postoperative nausea and vomiting Spinal anaesthesia contraindicated Inability to understand and use the numerical rating scale for pain assessment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 29/05/2021 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
22nd Guggisberg Avenue Accra Box 77 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to first request rescue analgesia or the time to a Numerical Rating Scale pain score of ≥4 Time elapsed in minutes following performance of the bilateral TAP block
Secondary Outcome Static and Dynamic Numerical Rating Scale pain scores in the first 24 hours after Caesarean Delivery 0, 2, 6, 12 and 24 hours following performance of TAP block
Secondary Outcome Amount of systemic opioid required for rescue analgesia in the first 24 hours after CD 24 hours following performance of TAP block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital 22nd Guggisberg Avenue Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 22nd Guggisberg Avenue Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Daniel Sottie 22nd Guggisberg Avenue Accra Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Sottie dsottie@gmail.com +233242137396 22nd Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Specialist Anaesthetist
Role Name Email Phone Street address
Public Enquiries Joojo Nyamekye Baidoo joobaidoo@gmail.com +233505411434 22nd Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Junior Resident
Role Name Email Phone Street address
Scientific Enquiries Ebenezer Owusu Darkwa eoddarquah@yahoo.co.uk +233244670149 22nd Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Consultant Anaesthetist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to make IPD and related data dictionaries available. All collected IPD will be made available. Informed Consent Form 2 years Controlled access based on email requested directly to the principal investigator. Criteria for review of requests will be based on qualification and quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information