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.: PACTR201704002165131 Date of Approval: 01/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TAP Block In Area with Limited Resources
Official scientific title Transversus Abdominis Plane Block after Cesarean Section in an Area with Limited Resources
Brief summary describing the background and objectives of the trial One of the most common major operations in Sub-Saharan Africa, in which Eritrea is located, is Caesarean Section. However, obstetric services including pain management are poorly developed. This results in significant suffering for mothers. Inadequate postoperative facilities and equipment and staff shortages limit the introduction of the more advanced options in a country like Eritrea. At the same time, single shot local anesthetic blocks which have a low incidence of adverse effects are underutilized.Therefore, the goal of this study was to find out if TAP block is effective and safe as part of multimodal pain management following Cesarean section, in an area with limited resources
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pain Management,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/12/2014
Actual trial start date 20/01/2015
Anticipated date of last follow up 10/09/2015
Actual Last follow-up date 10/02/2016
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 104
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 Patients with odd numbr assigned to the control group and patients with even number assigned to the TAP group Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP Block Group 0.3 ml/ kg of 0.25 % isobaric bupivacaine, Single injection in each side The injection was done only once (single shot) right after the last stitch. Patients were followed for 24 hours postoperatively The TAP Block group received a landmark orientated bilateral TAP block in the triangle of Petit with 0.3 ml / kg 0.25 % isobaric bupivacaine and the injection sites were covered with sterile gauze. The TAP block was done right after the last stitch. Therefore the injection was painless and could not be detected by the patients as they were still under spinal anaesthesia. 52
Control Group Control Group No medication or procedure was administered for this group. They had no interventions but they were followed for 24 hours postoperatively. After some manual manipulations at the site of the triangle of Petit, the control group received only a sterile cover in the area of the potential injection site to mask the participants and the observers. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Mothers with body mass index ¿ 30 kg/m2) ¿All mothers classified as ASA I/II ¿Patients under spinal anesthesia ¿All emergency and elective patients who are scheduled for Pfannenstiel incision under spinal anesthesia ¿Patients with any history of allergy to the drugs used in this study ¿Obesity (body mass index ¿ 30 kg/m2) ¿Local infection at the injection site of the TAP ¿Patients with cardiovascular, pulmonary and neurological diseases ¿Patients requiring general anesthesia for obstetric or anesthetic reasons ¿Patients undergoing upper segment caesarean section ¿Maternal or fetal compromise 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 03/09/2014 Health Research proposal Review and Ethics Commitee, Ministry of Health,Eritrea
Ethics Committee Address
Street address City Postal code Country
Ararib 174,Asmara,Eritrea Asmara 291 Eritrea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study was visual analog scale pain score in the first 24 postoperative hours VAS pain scores at rest, at deep breathing, during intentional cough and mobilization were measured at 2, 4, 6, 8, 12, 18 and 24h postoperatively
Secondary Outcome Reduction in the consumption of morphine and diclofenac postoperatively At 2, 4, 6, 8, 12, 18 and 24h postoperatively
Secondary Outcome Reduction in the postoperative side effects of morphine Side effects of morphine like respiratory depression, nausea and vomiting, sedation and pruritus were investigated on a three value scale (none, moderate, severe) at2, 4, 6, 8, 12, 18 and 24h postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orotta Maternity National Referral Hospital Denden,174 Asmara 291 Eritrea
FUNDING SOURCES
Name of source Street address City Postal code Country
Eritrea Research Fund Mai Bela Ave,Asmara, Eritrea Asmara 291 Eritrea
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Board For Higher Education Mai Bela Ave,Asmara, Eritrea Asmara 291 Eritrea Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr.Habteselassie Zerezgh Bahta Dembe Sembel, St.748-16, Block Number109, House Number 305 Asmara 291 Eritrea
Prof.Waltruad Elsholz Adishmagle Asmara 291 Eritrea
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Desale Tewelde Kahsay desale215@yahoo.com 00291292141 Adishmagle
City Postal code Country Position/Affiliation
Asmara 291 Eritrea Asmara collge of Health Sciences
Role Name Email Phone Street address
Public Enquiries Berhane Debru berhanebd59@gmail.com 002917141606 Ararib 174,Asmara Eritrea
City Postal code Country Position/Affiliation
291-1-122899 291 Eritrea Chairman of the Health research Proposal review and Ethical commitee of Ministry of Health
Role Name Email Phone Street address
Scientific Enquiries zemenfes Tsige zemenfest@gmail.com 00291-1-162133 Mai Bela Ave, Asmara, Eritrea
City Postal code Country Position/Affiliation
Asmara 219 Eritrea Director of postgratuat studies and Intrnational Linkage, National Board for Higher education
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information