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Trial registered on ANZCTR


Registration number
ACTRN12615000288527
Ethics application status
Approved
Date submitted
10/01/2015
Date registered
27/03/2015
Date last updated
7/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of epidural Dexmedetomidine as analgesic adjunct to local anesthetic in patients undergoing major abdominal cancer surgery
Scientific title
In major abdominal cancer surgery, does epidural dexmedetomidine added to bupivacaine, compared to epidural bupivacaine only, reduce postoperative opioid consumption?
Secondary ID [1] 285946 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain following major abdominal cancer surgery. 293877 0
Condition category
Condition code
Anaesthesiology 294178 294178 0 0
Anaesthetics
Cancer 294551 294551 0 0
Any cancer
Surgery 294552 294552 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before induction of anesthesia (pre-incision), for group BD, we will give epidural bolous dose of Dexmedetomidine 0.2 mic /kg added to 0.1 ml /kg of Bupivacaine 0.125%, then, we will give epidural infusion of Dexmedetomidine 0.2 mic /kg /h added to 0.1 ml /kg/h of Bupivacaine 0.125% for 48 h postoperatively . for group B, we will give epidural bolous dose of 0.1 ml /kg Bupivacaine 0.125%, then, we will give epidural infusion of 0.1 ml /kg/h of Bupivacaine 0.125% for 48 h postoperatively.
Intervention code [1] 290921 0
Treatment: Drugs
Comparator / control treatment
For group B (control group) we will give epidural bolous dose of 0.1 ml /kg Bupivacaine 0.125%, then, we will give epidural infusion of 0.1 ml /kg/h of Bupivacaine 0.125% for 48 h postoperatively.
Control group
Active

Outcomes
Primary outcome [1] 293970 0
postoperative opioid consumption of patients recorded by research nurse.
Timepoint [1] 293970 0
48 hours postoperatively
Secondary outcome [1] 312256 0
pain intensity by visual analogue scale
Timepoint [1] 312256 0
pain intensity by visual analogue scale assessed at 2h, 4 h, 8 h, 16 h, 24 h, 36 h and 48 h postoperatively

Eligibility
Key inclusion criteria
patients with physical status American Society of Anaesthesiologist (ASA) I , II and III who will undergo major abdominal cancer surgery will be enrolled into the study.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with coagulation abnormalities, spinal deformities, and patients allergic to amide type of local anesthetics or Dexmedetomidine will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6585 0
Egypt
State/province [1] 6585 0

Funding & Sponsors
Funding source category [1] 290528 0
Self funded/Unfunded
Name [1] 290528 0
diab fuad hetta
Address [1] 290528 0
10 soliman hakeem street, assuit city, 71111, egypt
Country [1] 290528 0
Egypt
Primary sponsor type
Individual
Name
diab fuad hetta
Address
10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Country
Egypt
Secondary sponsor category [1] 289223 0
Individual
Name [1] 289223 0
noha esmail ibrahim
Address [1] 289223 0
10 soliman hakeem street, assuit city, 71111, egypt
organization address: faculty of medicine, 1 university st., assuit city, 71111, egypt
Country [1] 289223 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292248 0
South Egypt Cancer institute-IRB IORG0006563
Ethics committee address [1] 292248 0
South Egypt Cancer institute, 2 El methaque street, 71111, Assuit city, Egypt.
Ethics committee country [1] 292248 0
Egypt
Date submitted for ethics approval [1] 292248 0
Approval date [1] 292248 0
11/01/2015
Ethics approval number [1] 292248 0

Summary
Brief summary
evaluation of analgesic efficacy of epiduraly administered dexmedetomidine when given as analgesic adjunct to bupivacaine 0.125% in postoperative period after major abdominal cancer surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53934 0
Dr diab fuad hetta
Address 53934 0
10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Country 53934 0
Egypt
Phone 53934 0
+201091090009
Fax 53934 0
Email 53934 0
diabhetta@gmail.com
Contact person for public queries
Name 53935 0
Dr diab fuad hetta
Address 53935 0
10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Country 53935 0
Egypt
Phone 53935 0
+201091090009
Fax 53935 0
Email 53935 0
diabhetta@gmail.com
Contact person for scientific queries
Name 53936 0
Dr diab fuad hetta
Address 53936 0
10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Country 53936 0
Egypt
Phone 53936 0
+201091090009
Fax 53936 0
Email 53936 0
diabhetta@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary