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.: PACTR201305000546300 Date of Registration:
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postoperative pain management
Official scientific title Multimodal analgesia in comparison with single agent analgesia for postoperative pain
Brief summary describing the background and objectives of the trial Multimodal analgesia in comparison with single agent analgesia for postoperative pain Post operative pain management has been reported to reduce morbidity and complications and accelerate rehabilitation and healing in surgical patients. Opioids is well known to reduce postoperative pain through its action on central opioid receptors , nevertheless , high doses of opioids are not desired particularly in ambulatory anesthesia because of its adverse events , nausea, vomiting ,pruritis and respiratory depression) which delay hospital discharge. The purpose of the current study is to define the role of each individual analgesic and the effects of combination of different analgesic drugs in the context of post-operative pain. ASA I and II Patients will be randomly assigned into one of 5 groups; control, NSAI, opioid, multiple analgesic and paracetamol. the primary outcome variables will be first request for analgesia and pain score will be statistically compared. NIBP, Spo2, end tidal CO2, O2 N2O % and anesthetic concentration will be monitored throughout the procedure..Time for first request will analyzed by (ANOVA ) analysis of variance followed by tuckey kramer that will be applied to pairwise comparison. Visual analogue score will be analyzed by Kruskal- Wallis and pairwise comparisons by steel ¿Dwas-flinger procedure/two tailed test to conserve statistical power using the XL stat 2013 program. P value > 0.05 will be considered significant.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 11/05/2013
Actual trial start date 23/05/2013
Anticipated date of last follow up 23/07/2013
Actual Last follow-up date 24/06/2013
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL published
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 patients numbers from 1 to 100 are randomised by software ( true random) number ,sequance generator) programme then assigned by systematic randomisation by closing eye and putting finger on random numbers selecting one number randomly and each 5th no for the 1 st block and repition of the process selecting every 4th random no for the second block and so on generating 5 randomised blocks each of 20 which is assigned to group by coin tossing between random block so it is not possible to geuss which patient will be in which group allocation will be sent to the pharmacist who will blind the investigator by giving a code to each specific case number then the drug or saline will be sent to the examiner in strile syrings to be added to infusion bottle after infusion of 110 ml saline to give a space for medication 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 fentanyl 1mcglkg once control group 15 Active-Treatment of Control Group
Experimental Group morphine 0.1mg/kg once opioid group 15
Experimental Group diclfenac NA ( Voltarine) 75mg once Voltarine 15
Experimental Group paractamol (perfalgan) 1 gram once perfalgan 15
Experimental Group morphine plus voltarine plus perfalgan plus dexamethasone 0.05mg/kg plus75mg plus 1 gram plus 8 mg respectively once multiple analgesic 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 1 and ASA 2 patients both adult male and female will undergoe short surgical procedure Asthmaic patients peptic ulcer patient drug allergies cancer patients 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
No 13/05/2013 elmenoufiya university
Ethics Committee Address
Street address City Postal code Country
gamal abdelnasser street Shebin Elkom NA Egypt
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 13/05/2013 Menoufia university
Ethics Committee Address
Street address City Postal code Country
Gamal Abdelnasser street Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome first request for analgesia after recovery when patient asks 180 minutes end point
Primary Outcome visual analogue pain score when patient feels pain or 180minutes passed
Secondary Outcome reduction in opioid dosage on request for analgesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elmenoufiya university gamal abdelnasser street Shebin Al-Kom NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
department of anethesia menoufia university hospitals shebin elkom na Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor elmenoufiya university hospitals gamal abdelnasser street shebin elkom na Egypt University
COLLABORATORS
Name Street address City Postal code Country
Magdy Sheehatah ain shams cairo na Egypt
montaser S. Abulkassem elshatby Alxandria na Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem Elsersy hazelsersy@hotmail.com 0020482237466 89 Saad Zagloul Street
City Postal code Country Position/Affiliation
Shebin Elkom na Egypt lecturer of anethesia elmenoufiya university
Role Name Email Phone Street address
Public Enquiries Montaser Abulkassem montaseabulkassem@yahoo.com 00966563821062 elshatby
City Postal code Country Position/Affiliation
Alexandria na Egypt assistent professor of anethesia, elmenoufiya university
Role Name Email Phone Street address
Scientific Enquiries Hazem Elsersy hazelsersy@hotmail.com 0020482237466 89 saad zagloul street
City Postal code Country Position/Affiliation
shebin elkom na Egypt lecturer of anethesia, elmenoufiya university
REPORTING
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