Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000482561
Ethics application status
Approved
Date submitted
29/04/2015
Date registered
15/05/2015
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Saphenous Nerve Block in Hamstring Anterior Cruciate Ligament Reconstruction Affect Postoperative Pain? A Randomised Controlled Trial
Scientific title
Effect of saphenous nerve block versus no block on patient perception of pain in patients undergoing ACL reconstruction with ipsilateral hamstring autograft
Secondary ID [1] 286611 0
nil
Universal Trial Number (UTN)
U1111-1168-8534
Trial acronym
ACL block study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction 294920 0
Condition category
Condition code
Anaesthesiology 295170 295170 0 0
Pain management
Surgery 295240 295240 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saphenous nerve block for patients undergoing ACL reconstruction with hamstring autograft. This involves 15cc 0.5% Ropivacaine (75mg) with an ultrasound guided approach picking a spot 10 cm above the patella, after general anaesthesia.

Both groups will receive multimodal analgesia. This includes IV paracetamol 1g 20min before the end of the case, and Parecoxib 40mg IV during the case. Surgeons will infiltrate hamstring site and knee joint with Ropivacaine 2mg/kg and 10mg of Morphine into the knee joint (intra-articular).
Intervention code [1] 291738 0
Treatment: Drugs
Comparator / control treatment
No saphenous nerve block for patients undergoing ACL reconstruction with hamstring autograft.

Both groups will receive multimodal analgesia. This includes IV paracetamol 1g 20min before the end of the case, and Parecoxib 40mg IV during the case. Surgeons will infiltrate hamstring site and knee joint with Ropivacaine 2mg/kg and 10mg of Morphine into the knee joint (intra-articular).
Control group
Active

Outcomes
Primary outcome [1] 294930 0
Post-operative pain assessed using a visual analogue scale.
Timepoint [1] 294930 0
Immediate Post surgery, 4 hours post surgery, 8 hours post surgery, 24 hours post surgery
Secondary outcome [1] 314373 0
Opiate use will be measured based on anaesthetic perioperative record and medication chart.
Timepoint [1] 314373 0
First 24 hours post surgery while patient is an inpatient.

Eligibility
Key inclusion criteria
All patients undergoing ACL reconstruction with ipsilateral hamstring autograft at our practice.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Previous ligamentous ipsilateral knee surgery
b. Concurrent surgery on contralateral limb
c. Any other graft use
d. Lack of adequate English as this would inhibit VAS score
e. Allergy or contraindication to Tramadol, Morphine, Fentanyl, Parecoxib, Ropivacaine, Postop NSAIDS, Paracetamol
f. Neurological disease involving peripheral nerves
g. Chronic pain issues
h. Drug addiction or tolerance with analgesics
i. Age less than 16

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)
All patients undergoing ACL reconstruction at Unisports with hamstring autograft will be given the option to enrol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is via computer generated random number list. Concealment of allocation is established by using sealed numbered envelopes allocated only when patients have signed the consent to enter the trial. The anaesthetist then opens the envelope prior to treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power was calculated based on previous similar studies. To detect a difference of 2 in visual analogue scale with 80% power and 0.05 beta value, we require 20 patients in each group. We are aiming for 30 patients in each group to achieve 90% power.

VAS scores and opiate consumption will be compared between control and intervention group, after performing normal distribution test on the data. Linear regression analysis will be performed to look for correlation between outcomes and patient baseline characteristics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2015
Actual
22/05/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
2/02/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6848 0
New Zealand
State/province [1] 6848 0
Auckland

Funding & Sponsors
Funding source category [1] 291179 0
Commercial sector/Industry
Name [1] 291179 0
Unisports Ltd. Please note that this is a group of surgeons that are carrying out the study. It is not a commercial entity.
Country [1] 291179 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Unisports Ltd
Address
71 Merton Road
Auckland 1743
Country
New Zealand
Secondary sponsor category [1] 289859 0
None
Name [1] 289859 0
none
Address [1] 289859 0
none
Country [1] 289859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292751 0
Central HDEC
Ethics committee address [1] 292751 0
PO BOX 5013
Wellington 6011
Ethics committee country [1] 292751 0
New Zealand
Date submitted for ethics approval [1] 292751 0
Approval date [1] 292751 0
28/04/2015
Ethics approval number [1] 292751 0
15/CEN/38

Summary
Brief summary
Reconstruction of anterior cruciate ligament (ACL) of the knee is a common procedure. Perioperative analgesia for ACL reconstruction using hamstring autograft can be achieved with multimodal analgesia +/- addition of nerve block. Saphenous nerve block is commonly used in our practice for patients undergoing ACL reconstruction.

Performing a saphenous nerve block adds cost, time and complications (overall rare) to the overall procedure with a perceived benefit of reduced opiate requirement and increased patient comfort. The benefit of saphenous nerve block for hamstring autograft ACL reconstruction has not been established in the literature.

We hypothesize that saphenous nerve block in ACL reconstruction with hamstring autograft does not improve patient comfort.
Trial website
none
Trial related presentations / publications
None, in the process of writing a manuscript
Public notes

Contacts
Principal investigator
Name 56854 0
Mr Ritwik Kejriwal
Address 56854 0
Unisports
71 Merton Rd
Auckland 1743
Country 56854 0
New Zealand
Phone 56854 0
+64 21 620586
Fax 56854 0
Email 56854 0
[email protected]
Contact person for public queries
Name 56855 0
Mr Ritwik Kejriwal
Address 56855 0
Unisports
71 Merton Rd
Auckland 1743
Country 56855 0
New Zealand
Phone 56855 0
+6421620586
Fax 56855 0
Email 56855 0
[email protected]
Contact person for scientific queries
Name 56856 0
Mr Ritwik Kejriwal
Address 56856 0
Unisports
71 Merton Rd
Auckland 1743
Country 56856 0
New Zealand
Phone 56856 0
+64 21620586
Fax 56856 0
Email 56856 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.