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.: PACTR201507000961407 Date of Approval: 06/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Continuous wound infusion
Official scientific title A comparative study between continuous wound infusion using Bupivacaine and Bupivacaine with Dexmedetomidine on post-operative analgesia after inguinal hernia repair
Brief summary describing the background and objectives of the trial The aim of the study is to assess the effects of addition of Dexmedetomidine to wound infusion with Bupivacaine on post-operative pain and the required analgesics in patients undergoing open inguinal hernia repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied acute post-operative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2014
Actual trial start date 15/01/2014
Anticipated date of last follow up 01/01/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2227/12/13 Research ethics committee, Faculty of Medicine, Tanta University
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 permuted block randomization of varying sizes Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal saline group 4 ml/h from 96 ml normal saline 24 h continuous wound infusion 25 Dose Comparison
Experimental Group Bupivacaine group 4 ml/h 0.25 % bupivacaine from 96 ml solution prepared by adding 48 ml 0.5% bupivacaine to 48 ml normal saline 24 h continuous wound infusion 25
Experimental Group Bupivacaine Dexmedetomidine group 4 ml/h from 96 ml solution which contains 0.25% bupivacaine and 0.8 - 1 micg/kg dexmedetomidine prepared by adding 16 ml dexmedetomidine (1600 micg) and 48 ml 0.5% bupivacaine to 32 ml normal saline 24 h continuous wound infusion 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA class I and II age 18-60 either gender scheduled for open inguinal hernia repair history of cardiac disease impaired renal or hepatic function coagulation disorders hypertensive patients treated with ¿-methyldopa, clonidine or ¿-adrenergic blockers using opioid or non-opioid analgesics within the previous 72 h contraindication to the study drugs. 18 Year(s) 60 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 31/12/2013 Research Ethics Committee, Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Albahr street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue pain scale (VAS) 1/2h 1h 3h 6h 12h 24h
Primary Outcome rescue analgesia: pethidine consumption on need
Secondary Outcome mean aterial blood pressure(MAP) , heart rate (HR) 1/2 h 1h 3h 6h 12h 24h
Secondary Outcome adverse effects: nausea, vomiting, sedation, local anesthetic toxicity, local inflammation or infection if occured
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine, Tanta University Albahr street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine. Tanta University Albahr street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Anesthesia and Surgical ICU, Tanta University Hospital Albahr street Tanta Egypt Hospital
Primary Sponsor Faculty of Medicine. Tanta University Albahr street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Ahmed Ali Aldaba 6 Abdelwahab street Tanta Egypt
Dr Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Aldaba go2eldaba@yahoo.com 01223433573 6 Abdelwahab street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Professor, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk ShaimaaFarouk7777@yahoo.com 01270440771
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Farouk ShaimaaFarouk7777@yahoo.com 01270440771
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Farouk ShaimaaFarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
REPORTING
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