Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12606000421538
Ethics application status
Approved
Date submitted
27/09/2006
Date registered
29/09/2006
Date last updated
29/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of three techniques for analgesia following total knee joint replacement: Continuous femoral nerve block or spinal morphine or a combination.
Scientific title
A comparison of three techniques for analgesia following total knee joint replacement: Continuous femoral nerve block or spinal morphine or a combination.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia for total knee joint replacement 1390 0
Condition category
Condition code
Musculoskeletal 1484 1484 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective randomised controlled study has been designed to compare analgesia and side-effects of continuous femoral nerve block, spinal morphine and both combined. All patients will receive a spinal anaesthetic with 15-20mgs of bupiviacaine. Patients allocated to the continuous femoral nerve block group will have a femoral nerve block establised using a arrow StimuCath Continuous Nerve Block Kit and ropivacaine 0.75% with adrenaline 5mcg/ml. Patients who are allocated to the spinal morphine group or combination group will have 175mcg preservative-free morphine added to their spinal anaesthestic. Postoperatively, patients who have a continuous femoral nerve block will have an infusion of ropivacaine 0.2% commenced at 12mls per hour until the morning of postoperative day 2. All patient will have an intravenous patient controlled analgesia (PCA) infusion of morphine commenced on 1mg boluses with a lockout period of 7 minutes until the morning of postoperative day 2.
Intervention code [1] 1380 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2055 0
Visual Analogue Scale (VAS) pain score at rest and during continuous passive motion
Timepoint [1] 2055 0
At 4, 12, 24 and 48 hours post operatively.
Secondary outcome [1] 3545 0
Morphine consumption and local anasethestic consumption. Assessment of sensory block to ice over the distribution of the femoral nerve , sedation score, nausea score, incidence of urinary retention and incidence of pruritus.
Timepoint [1] 3545 0
On post operative days 1 and 2.

Eligibility
Key inclusion criteria
First time total knee joint replacement.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand PCA or VAS scores. Contraindication to spinal anaesthesia (eg. coagulopathy, moderate to severe aortic stenosis, skin infection over insertion site). Contraindication to femoral nerve block (eg. previous valscular surgery in the groin, infection over insertion site, inablity to palpate femoral artery). Contraindiction to spinal and IV morphine (eg. obsructive sleep apnoea). Allergy to study drugs. Containdication to COX-2 inhibitors (eg. renal impairment, ischaemic heart disease). Chronic pain.

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 opened at the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software PC-Plan was used to generate random allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
The patient, researchers, anaesthetists, surgeons and ward nursing staff will be blinded to spinal morphine/placebo administration.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1622 0
Charities/Societies/Foundations
Name [1] 1622 0
Abbott Australian Society of Anaesthetists research Grant
Country [1] 1622 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 1423 0
None
Name [1] 1423 0
No secondary sponsor
Address [1] 1423 0
Country [1] 1423 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27607 0
Address 27607 0
Country 27607 0
Phone 27607 0
Fax 27607 0
Email 27607 0
Contact person for public queries
Name 10569 0
Simone Said
Address 10569 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 10569 0
Australia
Phone 10569 0
+61 3 92884245
Fax 10569 0
Email 10569 0
[email protected]
Contact person for scientific queries
Name 1497 0
Dr David Olive
Address 1497 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 1497 0
Australia
Phone 1497 0
+61 3 92884245
Fax 1497 0
Email 1497 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.