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.: PACTR201707002432259 Date of Approval: 16/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic Efficacy of Transverse Abdominalis Plane and Ilioinguinal/Iliohypogastric Blocks For Patients Undergoing Cesarean Delivery Under Spinal Anes
Official scientific title Analgesic Efficacy of Transverse Abdominalis Plane and Ilioinguinal/Iliohypogastric Blocks For Patients Undergoing Cesarean Delivery Under Spinal Anesthesia Using The Landmark Technique, In Dilla University Referral Hospital, Southern Ethiopia, 2016/17.
Brief summary describing the background and objectives of the trial Anterior abdominal field blocks are techniques of perioperative pain relief in patients undergoing abdominal surgery including lower segment cesarean section. Special emphasis to parturients undergoing cesarean section two techniques of abdominal field blocks (TAP & II-IH), are practiced widely. Potential spread of local anesthetics to block pain impulse generated from T11-L1 for TAP block and blockade of ilioinguinal & iliohypogastric nerves with II-IH nerve blocks are the supposed mechanisms for pain relief for LSCS surgery. Using the landmark technique the choice between TAP & II-IH nerve blocks is not yet studied in parturients undergoing surgery to give birth. The general objective of this study is to compare the analgesic efficacy of landmark technique ilioinguinal/iliohyogastric and transverse abdominalis nerve blocks for patients undergoing elective cesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied prevention of post operative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/07/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 15/12/2017
Actual Last follow-up date 30/12/2017
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
Recruitment status Recruiting
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 randomisation will be lottery based technique using tossing coin sealed open envlopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP block 20 ml of 0.25%bupivacaine bilaterally will be given for 24 hours Tap block for post op pain relief followin cesearan section 43
Experimental Group ilioinguinal & iliohypogastric nerves block 8 ml of 0.25% bupivacaine bilaterally will be given 24 hours ilioinguinal & iliohypogastric nerves will be given for mother undergoing ceseran section for post operative pain relief 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Term ASA(amarican society of anesthesiology) I & II pregnant mothers aged 18-45 who are volunteer to participate in the study - Hypertensive disorders of pregnancy (eclampsia, pre-eclampsia) - Progressive neurologic disease - Allergy to local anesthetics, NSAIDs, opioids - Infection at the site - Spinal anesthesia converted to general anesthesia because of total spinal or inadequate block - BMI > 40 mg/m2 - Peptic ulcer disease - Local anesthetic other than bupivacaine for either the spinal or block 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
No 30/07/2017 Wosen Admasu
Ethics Committee Address
Street address City Postal code Country
Piassa Addis Ababa 196 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/07/2017 Habtamu getnet
Ethics Committee Address
Street address City Postal code Country
Dilla hospital akebabi Dilla 234 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/07/2017 Amare Hailekiros
Ethics Committee Address
Street address City Postal code Country
Dilla hospital akebabi Dilla 245 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ To compare postoperative pain severity between the two groups using the NPS among pregnant mothers undergoing CD under spinal anesthesia, At 0 hr,immediately in recovery room. At 2 hrs. At 4hr. At 6hrs. At 8hrs. At 12hrs.
Secondary Outcome ¿ To determine the total postoperative analgesic consumption between the two groups among pregnant mothers undergoing CD under spinal anesthesia, after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla university Hospital dilla hospital akebabi Dilla 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla university St.Delemo Dilla 196 Ethiopia
Gedieo zonal health office St minilek Dilla 206 Ethiopia
souther ethiopia regional health office st. teno Hawassa 123 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor gedieo health office St.Delemo Dilla 206 Ethiopia Funding Agency
Secondary Sponsor souther ethiopia regional health office st. teno Hawassa 123 Ethiopia Funding Agency
Primary Sponsor Dilla university dilla hospital akebabi Dilla 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Ethiopian science and technology piassa Addis Ababa 213 Ethiopia
Dilla university anaesthesia departement Dilla university Hospital akebabi Dilla 145 Ethiopia
Dilla university hospital gynacology and obstetric departement Dilla university hospital akebabi Dilla 432 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sileshi Abiy kidusfitiwi@gmail.com +251-9-85-03-15-22 Dilla university hospital Akebabi
City Postal code Country Position/Affiliation
Dilla 196 Ethiopia Lecture
Role Name Email Phone Street address
Public Enquiries Akine Eshete simenehnigussie@gmail.com +251-9-18-44-12-03 piassa
City Postal code Country Position/Affiliation
Gondar 234 Ethiopia assistant professor of public Health
Role Name Email Phone Street address
Public Enquiries Akine Eshete simenehnigussie@gmail.com +251-9-18-44-12-03 Dilla university hospital Akebabi
City Postal code Country Position/Affiliation
Dilla 124 Ethiopia Assistant professor of public Health
Role Name Email Phone Street address
Scientific Enquiries Getachew Mergia girmaytg@yahoo.com +251-9-12-86-21-44 piassa
City Postal code Country Position/Affiliation
Dilla 324 Ethiopia Ass't Professor
REPORTING
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