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.: PACTR202011815473426 Date of Approval: 12/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY OF TRANS ABDOMINIS PLANE BLOCK FOR POST CESAREAN DELIVERY ANALGESIA AT KILIMANJARO CHRISTIAN MEDICAL CENTRE, TANZANIA MAY AND JUNE 2019: A RANDOMISED CONTROL TRIAL
Official scientific title EFFICACY OF TRANS-ABDOMINIS PLANE BLOCK FOR POST CESAREAN DELIVERY ANALGESIA IN LOW-INCOME COUNTRIES: A PHASE THREE FEASIBILITY STUDY.
Brief summary describing the background and objectives of the trial Proper pain control in patients undergoing caesarean section is essential for improving patients care with early functional recovery, mother-baby bond and breastfeeding. Good post-operative pain assessment and management is crucial to achieve this using multimodal pain management. For analgesia in post-operative period at to insure good recovery for mother and baby. Aim is to assess the efficacy of Transversus Abdominis Plane (TAP) block and satisfaction with pain control post cesarean delivery at Kilimanjaro Christian Medical Centre when added to pain management
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: Drugs
Anticipated trial start date 27/09/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 27/09/2020
Actual Last follow-up date 26/06/2019
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL https://fortuneonline.org/articles/efficacy-of-transabdominis-plane-block-for-post-cesarean-delivery-analgesia.pdf
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP group 30ml of 0.25% plain bupivacaine start each sides ( Left and right side of TAP area on anterior abdominal wall) Start At the end of the surgery, bilateral US (ultrasound) guided TAP block will be performed by one of the investigators using either 30ml of 0.25% plain bupivacaine (obtained by mixing 15 ml of 0.5% bupivacaine with 15 ml of normal saline). The procedure will be performed using aseptic technique. After preparing the skin with antiseptic solution, a linear high frequency ultrasound probe (6-13 MHz, Sonosite M- Turbo©) will be placed transversely on the anterolateral abdominal wall between the iliac crest and the costal margin. Under US guidance, the three layers of muscles -external oblique, the internal oblique, and the transversus abdominis will be identified. A 21-gauge, 100-mm needle will be attached with flexible tubing to a syringe filled with saline will be used to perform the block. The needle will then be introduced through the skin anteriorly in the plane of the ultrasound beam and advanced into the fascial plane between the internal oblique and transversus abdominis muscles with its tip lying in the mid axillary line. To assist with identifying these structures, the probe will be moved anteriorly to the rectus sheath and the fascial planes followed laterally. The final position of the probe will be no further anterior than the anterior axillary line. Hydro dissection with saline (2-5 ml) will be used to separate the fascial layers. After aspiration to exclude inadvertent vascular puncture, a test dose of 1-2 ml of the drug will be injected to confirm needle placement. After a negative test dose, 30 ml of the study solution will be injected while closely observing for signs of toxicity (tinnitus, perioral, numbness, metallic taste in mouth, slurring of speech and mental status changes). TAP block will be performed in a similar fashion on the opposite side. 41
Control Group Control group 24hrs Even no intervened subjects received a standard spinal anesthetic consisting of 10mg of 0.5% hyperbaric bupivacaine. Heart rate, blood pressure & oxygen saturation were monitored in the operating room. All the subjects received pethidine 100mg IM before the completion of the surgery as normal regimen in hospital then followed up at 0.6,12 and 24hrs 31 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with American Society of Anesthesiologists physical status II and III planned for surgery will be enrolled in this study. Patients with communication difficulties Patients who were obese. Any contraindication to spinal anesthesia or operated by general anaesthesia Patients allergic to amino-amide local anesthetics Patients with coagulopathy Patients with local skin infection at needle puncture sites Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 27/11/2019 KCMUCo Research Ethics Review Committee with No.2394
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 2240,KCMC Moshi 2240 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain scores 6 hrs , 12hrs and 24hrs
Primary Outcome Pain score on physical activities 6 hrs , 12hrs and 24hrs
Primary Outcome Satisfaction 24
Secondary Outcome Complications 0 hrs , 6hrs, 12hrs and 24hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre P.O. Box 3010 Moshi United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Evans Sanga P.O. Box 3010 Moshi United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Evans Sanga P.O. BOX 3010 Moshi Moshi 225 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Shuweikha Salim Mohamed P.O. BOX 80510 VOI Kenya
Dr ROGERS TEMU P.O.BOX 3010 MOSHI United Republic of Tanzania
Dr MWEMEZI KAINO P.O.BOX 3010 MOSHI United Republic of Tanzania
Dr. Ansbert Sweetbert Ndebea P.O. BOX 3010 MOSHI United Republic of Tanzania
Dr Bernard Njau P.O. BOX 3010 MOSHI United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Evans Sanga evansnga@hotmail.com +255718777701 BOX 31010
City Postal code Country Position/Affiliation
MOSHI 255 United Republic of Tanzania Kilimanjaro Christian Medical Centre
Role Name Email Phone Street address
Public Enquiries Shuweikha Mohamedi shuweikha87@gmail.com +254700010640 BOX 80510
City Postal code Country Position/Affiliation
Mombasa Kenya Kilimanjaro Christian Medical College
Role Name Email Phone Street address
Scientific Enquiries Mwemezi Kaino evansnga@hotmail.com +255688470271 Moshi
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Killimanjaro Christian Medical Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patient Data results sharing statement in protocol states Yes information will be shared to Individual participant dat the underlie the results reported in this article after deidentification such as table, figures, graphs. Document available will be clinical study report, Informed consent . This will be beginning of 2 months and 5 months following article publication Investigators whos proposed use of dat has been approved by independent review committee For individual data in meta-analysis "Information derived from this study will be shared at the departmental level, and hospital level. A copy of results will be made available at the KCMUCo library. after 24 months following article published. Results derived from study will be submitted for publication in national or international and peer journals. No any participant individual detail will be shared only analyzed results. Clinical Study Report,Informed Consent Form This will be beginning of 2 months and 5 months following article publication control
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/11/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information