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.: PACTR201505001138361 Date of Approval: 09/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic efficacy of caudal dexamethasone combined with ropivacaine in day case herniotomy
Official scientific title Analgesic efficacy of caudal dexamethasone combined with ropivacaine in day case herniotomy
Brief summary describing the background and objectives of the trial Caudal epidural administration of local anaesthetic agents has been found to be an effective form of analgesia in the early post operative period in for most day case procedures below the umbilicus. The popularity of the technique is due to the ease of administration, frequent success and safety. This study aims to compare the analgesic efficacy of caudal ropivacaine and dexamethasone versus caudal ropivacaine alone in children undergoing unilateral day-case herniotomy in the intraoperative and postoperative period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hernia, Herniotomy,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 09/05/2015
Actual trial start date
Anticipated date of last follow up 09/02/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical clearance number: ERC/2014/06/01 Ethical clearance from OAUTHC (international registration number: IRB/IEC/0004553).
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 Rn Sealed opaque envelopes will be picked and handed over to the person allocating the participants to the intervention arms. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple Rn Sealed opaque envelopes will be picked and handed over to the person allocating the participants to the intervention arms. 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 Ropivacaine and Dexamethasone 1.5 ml kg -1 of 0.15% ropivacaine and 0.1mg kg-1 of dexamethasone once Caudal epidural 34
Experimental Group Ropivacaine 1.5 ml kg -1 of 0.15% ropivacaine Once Once 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged between one and six years in the American Society of Anesthesiologists physical class I and II who are scheduled to undergo unilateral herniotomy exclusively as day case procedures. ¿ Parent or guardians¿ refusal. ¿ Patients with known allergy to ropivacaine or dexamethasone. ¿ Patients on steroid therapy. ¿ Patients with sacral abnormalities. ¿ Patients with spina bifida. ¿ Patients with infection at the injection site. ¿ Patients with coagulopathy. ¿ Use of analgesic medication or drugs that modify perception of pain. ¿ Previous/Recurrent Inguinal Hernia 1 Year(s) 6 Year(s) Both
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 OAUTHC Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Ife Ilesa Ife 220222 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain 30mins post herniotomy 60mins post herniotomy 120mins post herniotomy 180mins post herniotomy Time of administration of oral paracetamol in mins, post herniotomy
Secondary Outcome Parents or gaurdians satisfaction 24hrs post herniotomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ife-Ilesa Express Ile-Ife 220222 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adeyeye A. House 9b OAUTHC 220222 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adeyeye Adedayo OAUTHC Osun state 220222 Nigeria Hospital
Secondary Sponsor Adeyeye Adeolu Ife-Ilesa Express Ile-Ife 220222 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Adeyeye Adedayo Ife-Ilesha expressway Ife 220222 Nigeria
Faponle Folayemi Ife-Ilesa Express Ile-Ife 220222 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adedayo Adeyeye dayo_oguntade@yahoo.com 08138952346 Ife-Ilesha Expressway
City Postal code Country Position/Affiliation
Ife 220222 Nigeria Medical Doctor/ Obafemi Awolowo University Teaching Hospital Ile-Ife
Role Name Email Phone Street address
Public Enquiries Adeolu Adeyeye contact_deo@yahoo.com 07030393246 Ife
City Postal code Country Position/Affiliation
Osun state 220222 Nigeria Medical Doctor/Ondo State Trauma and Surgical Center, Ondo.
Role Name Email Phone Street address
Scientific Enquiries Adedayo Adeyeye adedayo_oguntade@yahoo.com 08138952346 OAUTHC staff quarters, Ife-Ilesha Express way
City Postal code Country Position/Affiliation
Osun state 220222 Nigeria Medical Doctor/ Obafemi Awolowo University Teaching Hospital Ile-Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information