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Trial registered on ANZCTR


Registration number
ACTRN12614000441617
Ethics application status
Approved
Date submitted
10/04/2014
Date registered
29/04/2014
Date last updated
29/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spinal Dexamethasone added to Bupivacaine and Caudal block in Pediatric Lower Extremity Orthopedic Surgery. A Prospective Comparative Study
Scientific title
The effect of spinal Dexamethasone added to bupivacaine versus caudal block on duration of block and postoperative analgesia in pediatric lower extremity orthopedic surgery
Secondary ID [1] 284413 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology for pediatric lower extremity orthopedic surgical procedures 291613 0
Condition category
Condition code
Anaesthesiology 291986 291986 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group I (spinal group): dexamesthazone 0.1 mg/ kg added to hyperbaric bupivacaine (0.5 %) given interathecally

Group II (caudal group): isobaric bupivacaine 1.2 ml/kg (0.25%) given caudally.
Intervention code [1] 289162 0
Treatment: Drugs
Comparator / control treatment
isobaric bupivacaine 1.2 ml/kg (0.25%) given caudally as active control group.
Control group
Active

Outcomes
Primary outcome [1] 291885 0
comparing the duration of spinal block after addition of dexamethasone versus the duration of caudal blockade

The extent of the sensory block is checked by pin- prick every minute till establishment of sensory block.

Motor block clinically checked by, lack of leg movement

successful block ( absence of any gross purposeful muscular movement),

duration of block (defined by return of forceful movement of the legs) measured by minutes.
Timepoint [1] 291885 0
successful block ( absence of any gross purposeful muscular movement),

duration of block (defined by return of forceful movement of the legs) measured by minutes.
Secondary outcome [1] 307734 0
assess quality of analgesia and motor block postoperative

The quality of analgesia assessed by using an observational pain scale (OPS) assesses parameters (crying, movement, agitation, verbalization and BP change) each parameter was given a score of 0-2.

Bromage scale for assessing motor block. (0 = Able to raise straight leg, full flexion of knee and feet. 1 = Inability to raise leg, able to flex knees. 2 = Inability to flex knees, able to flex ankles. 3 = Inability to flex ankles.)
Timepoint [1] 307734 0
Patients were evaluated every 1 hour for the first 4 hours postoperative
Secondary outcome [2] 307858 0
perioperative complications were recorded (bradycardia, tachycardia, shivering, headache, urine retention or nausea and vomiting).
Timepoint [2] 307858 0
during intraoperative and first 4 hours postoperative

Eligibility
Key inclusion criteria
patients aged between 1 – 6 years, both males and females, ASA physical status I and II scheduled for lower extremity orthopedic surgical procedures were included in this study.
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
refusal of the parents, infection at the site of the block, bleeding diathesis, children with neurological disorders, and children with known allergy to give local anesthetics.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomized into two equal groups of patients via a table of random numbers using a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Data are presented as mean +/- (SD) for normally distributed data. Baseline characteristics and outcomes across the groups were compared using the Student's t-test for continuous variables and chi-square analysis for nominal data. All analysis has been calculated using SPSS V.16. A P-value of <0.05 was considered to indicate statistical significance.

The primary point was increase duration of spinal anesthesia in compare to caudal anesthesia duration. For each group for each group 26 patients were required for dexamethasone to increase the mean value of duration by 20% based on a previous pilot study in our institute a = 0.05 and a power of 0.8 with 95% confidence interval.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2012
Actual
26/11/2012
Date of last participant enrolment
Anticipated
24/10/2013
Actual
24/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 5995 0
Egypt
State/province [1] 5995 0
Tanta / Gharbia

Funding & Sponsors
Funding source category [1] 289072 0
Self funded/Unfunded
Name [1] 289072 0
Rehab S. ELkalla
Country [1] 289072 0
Egypt
Primary sponsor type
Individual
Name
Rehab S. ELkalla
Address
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt
Country
Egypt
Secondary sponsor category [1] 287734 0
Individual
Name [1] 287734 0
Mohamad G. Ayaad
Address [1] 287734 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt
Country [1] 287734 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290865 0
institutional ethics committee of the Faculty of Medicine, Tanta University
Ethics committee address [1] 290865 0
Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Ethics committee country [1] 290865 0
Egypt
Date submitted for ethics approval [1] 290865 0
Approval date [1] 290865 0
19/11/2012
Ethics approval number [1] 290865 0

Summary
Brief summary
Addition of dexamethasone was found to prolong duration of spinal block in adults. The primary outcome of this study is comparing the duration of spinal block after addition of dexamethasone and the duration of caudal blockade, Secondary outcome is to assess quality of pain relief and muscle relaxation with hemodynamic stability and rapid recovery between the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47622 0
Dr Rehab S. ELkalla
Address 47622 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country 47622 0
Egypt
Phone 47622 0
+201285700765
Fax 47622 0
Email 47622 0
[email protected]
Contact person for public queries
Name 47623 0
Dr Mohamad G. Ayaad
Address 47623 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country 47623 0
Egypt
Phone 47623 0
+201128396916
Fax 47623 0
Email 47623 0
[email protected]
Contact person for scientific queries
Name 47624 0
Prof Abd ELRahim Dowidar
Address 47624 0
Department of Anesthesia and surgical Intensive care, Faculty of Medicine, Tanta University, Egypt.
EL Geish st.
Tanta / Gharbia
31257
Egypt.
Country 47624 0
Egypt
Phone 47624 0
+201223195015
Fax 47624 0
Email 47624 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
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