Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
PACTR |
Last refreshed on:
|
29 May 2023 |
Main ID: |
PACTR201704002165131 |
Date of registration:
|
01/04/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
TAP Block In Area with Limited Resources
|
Scientific title:
|
Transversus Abdominis Plane Block after Cesarean Section in an Area with Limited Resources |
Date of first enrolment:
|
30/12/2014 |
Target sample size:
|
108 |
Recruitment status: |
Complete |
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2165 |
Study type:
|
Interventional |
Study design:
|
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
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Eritrea
| | | | | | | |
Contacts
|
Name:
|
Berhane
Debru |
Address:
|
Ararib 174,Asmara Eritrea
291
291-1-122899
Eritrea |
Telephone:
|
002917141606 |
Email:
|
berhanebd59@gmail.com |
Affiliation:
|
Chairman of the Health research Proposal review and Ethical commitee of Ministry of Health |
|
Name:
|
zemenfes
Tsige |
Address:
|
Mai Bela Ave, Asmara, Eritrea
219
Asmara
Eritrea |
Telephone:
|
00291-1-162133 |
Email:
|
zemenfest@gmail.com |
Affiliation:
|
Director of postgratuat studies and Intrnational Linkage, National Board for Higher education |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: ¿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
Exclusion criteria: ¿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
Age minimum:
18 Year(s)
Age maximum:
45 Year(s)
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Pain Management
|
Surgery
|
Surgery Pain Management
|
Intervention(s)
|
|
TAP Block Group
|
Control Group
|
Primary Outcome(s)
|
The primary outcome of the study was visual analog scale pain score in the first 24 postoperative hours
|
Secondary Outcome(s)
|
Reduction in the consumption of morphine and diclofenac postoperatively
|
Reduction in the postoperative side effects of morphine
|
Source(s) of Monetary Support
|
Eritrea Research Fund
|
Ethics review
|
Status: Approved
Approval date: 03/09/2014
Contact:
Health Research proposal Review and Ethics Commitee, Ministry of Health,Eritrea
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|