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.: PACTR201304000486309 Date of Approval: 16/01/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Use of Nalpuphine in post operative pain
Official scientific title Does Gender Affect the Response to the Use of Intravenous Nalbuphine for Post Operative Analgesia after Major Abdominal Surgery; A multicenter Study
Brief summary describing the background and objectives of the trial The current study is designed to compare the effect of various doses of Nalbuphine used as continuous infusion for post operative pain control after major abdominal surgery between male and female gender.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) GDRN
Disease(s) or condition(s) being studied Gender Difference in Response to Nalpuphine, post operative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/02/2013
Actual trial start date
Anticipated date of last follow up 01/07/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GROUP 1 MALE 1 MG AS NEED 12 HRS POSTOPERATIVE ANALGESIC EFFECT 40
Experimental Group GROUP 2 MALE 2 MG AS NEED 12 HRS POST OPERATIVE ANALGESIC EFFECT 40
Experimental Group GROUP 3 FEMALE 1 MG AS NEED 12 HRS POST OPERATIVE ANALGESIC EFFECT 40
Experimental Group GROUP 4 FEMALE 2 MG AS NEED 12 HRS POST OPERATIVE ANALGESIC EFFECT 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age: 18-65 years old 2-Male & Female patients of ASA physical status I to III 3-Scheduled for elective major abdominal surgery 1-Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders or drug abuse 2-Intraoperative fentanyl use 3-Patients with definite diagnosis of esophageal reflux syndrome 4-Usage of sedatives, antiemetics or antipruritics within 24 hours before operation 5-Surgery (more than 4 hours or laparoscopy) 19 Year(s) 65 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 15/05/2013 Dar El Fouad Hospital
Ethics Committee Address
Street address City Postal code Country
26th. July street 6th. of October City 12568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain with reference to Gender Pre-operative post operative: 3 hrs post operative: 6 hrs post operative: 9 hrs post operative: 12 hrs
Secondary Outcome side effects post operative: 3 hrs post operative: 6 hrs post operative: 9 hrs post operative: 12 hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El Foad Cairo Egypt
South Valley University Hospital Quena Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amoun Pharmaceutical Company El Obour El Obour City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dar El Foad Hospital Cairo Egypt Commercial Sector/Industry
Secondary Sponsor Amoun Pharmaceutical Company El Obour Obour City Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Amany E. Ayad, MD, FIPP Dar El Foad Hospital Cairo Egypt
Prof.Dr.Adel Mishriky, MD 27, Atteya El Kholy st., Nasr City Egypt
Prof. Dr. Ossama Salman Qena faculty of medicine, qena Qena 83523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Ayad amanymounir@yahoo.com 0122349325
City Postal code Country Position/Affiliation
Cairo Egypt Prof. of pain therapy & anesthesia
Role Name Email Phone Street address
Public Enquiries Ayman Onsy aonsy@amoun.com 46140100
City Postal code Country Position/Affiliation
Cairo Egypt Marketing Director
Role Name Email Phone Street address
Scientific Enquiries Dr.George Albert Bedros galbair@amoun.com 01006003042 Amoun Pharmaceutical Co.
City Postal code Country Position/Affiliation
Obour city, Cairo Egypt Medical Manager
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information