Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000640404
Ethics application status
Not yet submitted
Date submitted
12/12/2007
Date registered
17/12/2007
Date last updated
17/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective trial of selective ultrasound-guided obturator nerve blockade for total knee replacement.
Scientific title
Prospective trial on efficacy of selective ultrasound-guided obturator nerve blockade for total knee replacement
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing unilateral total knee replacement. 2623 0
Condition category
Condition code
Surgery 2740 2740 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selective ultrasound-guided obturator nerve blockade performed preoperatively (using ropivacaine 37.5-75mg), in addition to continuous femoral nerve blockade (ropivacaine 75-150mg) and spinal anaesthesia (isobaric bupivacaine 15-20mg). Postoperative analgesia provided by femoral nerve local anaesthetic infusion (ropivacaine 16-24mg/hr), and morphine patient-controlled analgesia device (morphine 1mg bolus at 5min lockout).
Intervention code [1] 2360 0
Treatment: Other
Comparator / control treatment
Continuous femoral nerve blockade (ropivacaine 75-150mg bolus) and spinal anaesthesia only (isobaric bupivacaine 15-20mg). Postoperative analgesia provided by femoral nerve local anaesthetic infusion (ropivacaine 16-24mg/hr), and morphine patient-controlled analgesia device (morphine 1mg bolus at 5min lockout).
Control group
Active

Outcomes
Primary outcome [1] 3628 0
Cumulative morphine requirements.
Timepoint [1] 3628 0
6hrs, 12hrs and 24hrs post-surgery
Secondary outcome [1] 6098 0
Block performance time
Timepoint [1] 6098 0
Measured during block placement, from time of needle insertion to time of needle removal.
Secondary outcome [2] 6099 0
Hip adductor strength
Timepoint [2] 6099 0
Measured at 6hrs post-surgery.
Secondary outcome [3] 6100 0
Cutaneous sensory deficit in obturator nerve distribution.
Timepoint [3] 6100 0
Measured at 6hrs post-surgery.
Secondary outcome [4] 6101 0
Visual analogue pain scores.
Timepoint [4] 6101 0
6hrs, 12hrs, 24hrs post-surgery.
Secondary outcome [5] 6102 0
Patient satisfaction.
Timepoint [5] 6102 0
Measured at 24hrs.
Secondary outcome [6] 6103 0
Complications.
Timepoint [6] 6103 0
Assessed at 10 days postoperatively.

Eligibility
Key inclusion criteria
Undergoing unilateral total knee replacement.
Communicative in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Without preexisting lower limb neurological deficits.
Without opioid tolerance.

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)
Screening for eligibility.
Following consent, randomisation by sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 517 0
3065

Funding & Sponsors
Funding source category [1] 2880 0
Hospital
Name [1] 2880 0
Department of Anaesthesia
Country [1] 2880 0
Australia
Primary sponsor type
Individual
Name
Timothy Lee
Address
Department of Anaesthesia, St Vincent's Hospital
Country
Australia
Secondary sponsor category [1] 2595 0
Individual
Name [1] 2595 0
Michael Barrington
Address [1] 2595 0
Department of Anaesthesia, St Vincent's Hospital
Country [1] 2595 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4818 0
Human Research Ethics Committee D
Ethics committee address [1] 4818 0
Research and Grants Unit,
St Vincent's Hospital,
Victoria Parade,
Fitzroy, Victoria 3065
Ethics committee country [1] 4818 0
Australia
Date submitted for ethics approval [1] 4818 0
03/07/2007
Approval date [1] 4818 0
Ethics approval number [1] 4818 0
070/07

Summary
Brief summary
Prospective trial of selective ultrasound-guided obturator block to determine its efficacy in providing analgesia following total knee joint replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28239 0
Address 28239 0
Country 28239 0
Phone 28239 0
Fax 28239 0
Email 28239 0
Contact person for public queries
Name 11396 0
Timothy Lee
Address 11396 0
Department of Anaesthesia,
St Vincent's Hospital,
Victoria Parade,
Fitzroy, Victoria 3065
Country 11396 0
Australia
Phone 11396 0
92882211
Fax 11396 0
Email 11396 0
[email protected]
Contact person for scientific queries
Name 2324 0
Timothy Lee
Address 2324 0
Department of Anaesthesia,
St Vincent's Hospital,
Victoria Parade,
Fitzroy, Victoria 3065
Country 2324 0
Australia
Phone 2324 0
92882211
Fax 2324 0
Email 2324 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.