Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000708550
Ethics application status
Approved
Date submitted
27/06/2015
Date registered
9/07/2015
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesic efficacy of paravertebral dexmedetomidine in children undergoing renal surgery
Scientific title
In children undergoing renal surgery, does paravertebral dexmedetomidine added to bupivacaine, compared to paravertebral bupivacaine only, reduce postoperative opioid consumption?
Secondary ID [1] 286991 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia for pediatric patients undergoing renal surgery 295450 0
Condition category
Condition code
Anaesthesiology 295701 295701 0 0
Anaesthetics
Surgery 295702 295702 0 0
Other surgery
Renal and Urogenital 295821 295821 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of anesthesia and before skin incision, for group PD, with the patient in the lateral decubitus position and the operated side facing upwards. Needle insertion will be made at an easily palpated single low thoracic level (Th10–12) lateral to the spinal process. The distance from the midline will be (approximating the distance between the patient’s two adjacent spinous processes). A 22 G Tuohy needle will be inserted perpendicularly to the skin in all planes until contact with the transverse process. The needle will be then advanced under or over the transverse process and after piercing the costo-transverse ligament, the paravertebral space was identified by loss of resistance to air. After careful aspiration, a single bolus dose of 0.5 ml / kg of Bupivacaine 0.25% and 1.5 mic /kg dexmedetomidine will be injected.
Intervention code [1] 292192 0
Treatment: Drugs
Comparator / control treatment
for group PB, a single bolus dose of 0.5 ml / kg of Bupivacaine 0.25% only will be injected in the paravertebral space in the low thoracic level (Th10–12)
Control group
Active

Outcomes
Primary outcome [1] 295410 0
postoperative opioid consumption of patients recorded by research nurse.
Timepoint [1] 295410 0
postoperative 24 h
Secondary outcome [1] 315528 0
Time to first analgesic request recorded by research nurse
Timepoint [1] 315528 0
postoperative 24 h
Secondary outcome [2] 315529 0
Pain intensity measured by visual analogue scale and FLACC score recorded by research nurse
Timepoint [2] 315529 0
postoperative, 0 h (immediately postoperative), 1h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h

Eligibility
Key inclusion criteria
1-Renal surgery
2-patients with physical status American Society of Anaesthesiologist (ASA) I , II and III
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-contraindication to PVB (infection at site of injection, coagulopathy, vertebral anomalies)
2- allergy to drugs used in 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
Recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 7004 0
Egypt
State/province [1] 7004 0

Funding & Sponsors
Funding source category [1] 291543 0
Self funded/Unfunded
Name [1] 291543 0
none
Country [1] 291543 0
Primary sponsor type
Individual
Name
diab fuad hetta
Address
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country
Egypt
Secondary sponsor category [1] 290222 0
Individual
Name [1] 290222 0
noha esmail ibrahim
Address [1] 290222 0
organization address: faculty of medicine, 1 university st., assuit university,
assuit city,71111, egypt
Country [1] 290222 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293087 0
faculty of medicine, assuit university ethical committee
Ethics committee address [1] 293087 0
organization address: faculty of medicine, 1 university st., assuit university, assuit city,71111, egypt
Ethics committee country [1] 293087 0
Egypt
Date submitted for ethics approval [1] 293087 0
15/08/2015
Approval date [1] 293087 0
28/08/2015
Ethics approval number [1] 293087 0

Summary
Brief summary
Evaluation of postoperative analgesic efficacy of paravertebral dexmedetomidine when added to bupivacaine in pediatric patients undergoing renal surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58414 0
Dr diab fuad hetta
Address 58414 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 58414 0
Egypt
Phone 58414 0
+201091090009
Fax 58414 0
Email 58414 0
[email protected]
Contact person for public queries
Name 58415 0
diab fuad hetta
Address 58415 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 58415 0
Egypt
Phone 58415 0
+201091090009
Fax 58415 0
Email 58415 0
[email protected]
Contact person for scientific queries
Name 58416 0
diab fuad hetta
Address 58416 0
organization address: south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 58416 0
Egypt
Phone 58416 0
+201091090009
Fax 58416 0
Email 58416 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.