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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: www.pactr.org

Trial no.: PACTR201304000486309 Date registered: 2013/01/16
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 Others
Acronym (If the trial has an acronym then please provide) GDRN
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2013-02-03
Actual trial start date
Anticipated date of last follow up 2013-07-01
Actual date of last follow up
Anticipated target sample size (number of participants) 160   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 Min age Max 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 Years 65 Years 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 2013/05/15 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 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 Qena Faculty of Medicine, Qena Qena 83523 Egypt
Wadi El Nile Hospital Cairo 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
Primary Sponsor Amoun Pharmaceutical Company Cairo Egypt Company

COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Amany E. Ayad, MD, FIPP Dar El Foad Hospital Cairo Egypt
Prof. Dr. Yehya Khatter Prof. of Anesthesia, Kasr El Aini 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 Fax
Principal Investigator Prof Amany Ayad amanymounir@yahoo.com 0122349325
Street address City Postal code Country Position / Affiliation
Cairo Egypt Prof. of pain therapy & anesthesia
Role Name Email Phone Fax
Public Enquiries Dr Ayman Onsy aonsy@amoun.com 46140100
Street address City Postal code Country Position / Affiliation
Cairo Egypt Marketing Director
Role Name Email Phone Fax
Scientific Enquiries Dr Dr.George Albert Bedros galbair@amoun.com 01006003042 +(20)46140186
Street address City Postal code Country Position / Affiliation
Amoun Pharmaceutical Co. Obour city, Cairo Egypt Medical Manager