Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000772943
Ethics application status
Approved
Date submitted
22/07/2011
Date registered
22/07/2011
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between intraarticular dexmedetomidine and morphine for postoperative analgesia after arthroscopic meniscal surgery
Scientific title
Comparison between intraarticular dexmedetomidine and morphine for postoperative analgesia after arthroscopic meniscal surgery
Secondary ID [1] 262682 0
Nil
Universal Trial Number (UTN)
U1111-1123-1121
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia 268384 0
Arthroscopy 268385 0
Condition category
Condition code
Anaesthesiology 268523 268523 0 0
Pain management
Surgery 268524 268524 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Intra-articular dexmedetomidine 1 mcg/kg (in 20 ml saline) before wound closure once
Arm 2: Intra-articular morphine 30 mcg/kg (in 20 ml saline) before wound closure once
Intervention code [1] 267025 0
Treatment: Drugs
Comparator / control treatment
Arm 3: Intra-articular saline 20 ml before wound closure once
Control group
Placebo

Outcomes
Primary outcome [1] 269270 0
Visual analogue scale (VAS) score (0-10) at rest
Timepoint [1] 269270 0
Before induction of anesthesia, on arrival to recovery room, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after surgery
Primary outcome [2] 269271 0
Visual analogue scale (VAS) score (0-10) on movement
Timepoint [2] 269271 0
Before induction of anesthesia, on arrival to recovery room, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after surgery
Secondary outcome [1] 279250 0
Observers Assessment of Alertness and Sedation (OAA/S) score
Timepoint [1] 279250 0
Before induction of anesthesia, on arrival to recovery room, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after surgery
Secondary outcome [2] 279251 0
Time to first analgesia request postoperatively (minutes)
Timepoint [2] 279251 0
Up to 48 hours postoperatively
Secondary outcome [3] 279252 0
Total amount of tramadol administered postoperatively
Timepoint [3] 279252 0
Up to 48 hours postoperatively

Eligibility
Key inclusion criteria
- American Society of Anesthesiologists’ physical class I or II
- Arthroscopic meniscal surgery under general anaesthesia
- Elective surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Regional anaesthesia
- History of opioids or sedative agents use on regular basis for more than a week prior to surgery
- renal impairment (serum creatinine > 200 mcg/ml)

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)
Patients are screened for eligibility by a reaserach assistant. After informed consent is obtained, study medication is prepared in pharmacy. Study group allocation is done using sealed serially numbered opaque envelopes based on the randomization schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is performed using a computer-generated randomization schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3744 0
Saudi Arabia
State/province [1] 3744 0

Funding & Sponsors
Funding source category [1] 267503 0
University
Name [1] 267503 0
Department of Anesthesia and Critical Care, King Abdulaziz University
Country [1] 267503 0
Saudi Arabia
Primary sponsor type
University
Name
King Abdulaziz University
Address
P.O. Box 80215
Jeddah 21589
Country
Saudi Arabia
Secondary sponsor category [1] 266545 0
None
Name [1] 266545 0
Address [1] 266545 0
Country [1] 266545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269468 0
Research and Ethics Committee
Ethics committee address [1] 269468 0
Department of Anesthesia and Critical Care
P.O. Box 80215
Jeddah 21589
Ethics committee country [1] 269468 0
Saudi Arabia
Date submitted for ethics approval [1] 269468 0
Approval date [1] 269468 0
29/03/2011
Ethics approval number [1] 269468 0
ANE08-11

Summary
Brief summary
This randomized double-blind study was designed to determine the analgesic effects of intra-articular dexmedetomidine and to compare it with those of morphine in patients undergoing arthroscopic knee surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32907 0
Address 32907 0
Country 32907 0
Phone 32907 0
Fax 32907 0
Email 32907 0
Contact person for public queries
Name 16154 0
Dr. Walid Almarakbi
Address 16154 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 16154 0
Saudi Arabia
Phone 16154 0
96626408335
Fax 16154 0
Email 16154 0
[email protected]
Contact person for scientific queries
Name 7082 0
Dr. Walid Almarakbi
Address 7082 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 7082 0
Saudi Arabia
Phone 7082 0
966-2-6408335
Fax 7082 0
Email 7082 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.