Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000834550p
Ethics application status
Submitted, not yet approved
Date submitted
20/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a custom anaesthetic solution on postoperative pain in hand surgery: a pilot study.
Scientific title
Effectiveness of a custom anaesthetic solution (combination of clonidine, adrenaline, ropivacaine, lidocaine, dexamethasone) on postoperative pain in hand surgery: a pilot study
Secondary ID [1] 312379 0
Nil known
Universal Trial Number (UTN)
U1111-1309-5324
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain management
 334170 0
dupuytren's disease
 334171 0
carpal tunnel syndrome 334172 0
hand surgery 334241 0
Condition category
Condition code
Anaesthesiology 330838 330838 0 0
Pain management
Surgery 330839 330839 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to either the custom solution (CLARD) group or conventional local anaesthetic (LR) group with a 1:1 ratio. The random selection will be performed on the day of surgery by the relevant investigator, who will choose an unmarked envelope from a predetermined number of envelopes containing the assignments in a 1:1 ratio. The relevant investigator will be blinded to the selection.
The conventional local anaesthetic group will receive a combination of 10ml plain 1% ropivacaine, 2ml 10% lidgnocaine, and 8ml normal saline (0.9% per 100ml), for a total of 20ml solution, via subcutaneous local infiltration with a 20ml syringe and 21 gauge needle. The CLARD group will receive a combination of 10ml 1% ropivacaine, 2ml compromised of 10% lidgnocaine + 8mg dexamethasone + 75mcg clonidine, 2ml 1:10,000 adrenaline, and 3.5ml normal saline, for a total of 17.5ml custom solution, via subcutaneous local infiltration with a 20ml syringe and 21 gauge needle. In order for the Anaesthesiologist to be blinded, they will draw up both solutions for each case. Their anaesthetic nurse (who will not be an investigator), will then hand the Anaesthetist the randomly drawn assignment to be infiltrated. A standardised anaesthetic technique and local anaesthetic administration method – subcutaneous local infiltration around the median, radial and ulnar nerves at the level of the proximal wrist crease - will be used for all cases. The local anaesthetic will be administered to participants 5 minutes prior to the start of surgery. All other aspects of the surgical procedure including prophylactic antibiotics, surgical technique and closure will be performed in a standardized manner by a single Plastic and Reconstructive Surgeon.
Postoperatively, patients will all receive the same pain management protocol on discharge, 2 tablets of Panadol Osteo three times a day regularly for 5 days then as required, and 10 tablets of Tapentadol Immediate Release 50-100mg for use 4 times a day as required. No anti-inflammatories will be provided on discharge and patients will be instructed not to take any in the post-operative study period.
At their first follow up appointment 1 week postoperatively, patients will be asked to complete a VAS detailing postoperative pain, and a questionnaire outlining time to first opiate usage and total opiate usage. Patients will also be followed up in hand therapy clinic for functional testing as well as hand therapy.
Intervention code [1] 328877 0
Treatment: Drugs
Comparator / control treatment
The conventional local anaesthetic group (control) will receive a combination of 10ml plain 1% ropivacaine, 2ml 10% lidgnocaine, and 8ml normal saline (0.9% per 100ml), for a total of 20ml solution, via subcutaneous local infiltration with a 20ml syringe and 21 gauge needle.
Control group
Active

Outcomes
Primary outcome [1] 338610 0
Total opioid analgesic consumption
Timepoint [1] 338610 0
6 weeks postoperatively
Secondary outcome [1] 436606 0
Time to first usage of opioid analgesia postoperatively
Timepoint [1] 436606 0
baseline, 2, 4, 6 and 8 weeks postoperatively
Secondary outcome [2] 436924 0
Subjective postoperative pain
Timepoint [2] 436924 0
Baseline, 2, 4, 6 and 8 weeks postoperatively
Secondary outcome [3] 436925 0
Hand function
Timepoint [3] 436925 0
All participants will have the above measures and their changes assessed pre-operatively, and two, four, and eight weeks post operatively.

Eligibility
Key inclusion criteria
The study will include patients >18 years of age who will receive either open carpal tunnel release, open fasciectomy for Dupuytrens disease or both procedures in the same operation at Holmesglen Private Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are <18 years of age, have evidence of cognitive impairment as formally diagnosed by a specialist physician or neuropsychologist, or have a history of chronic pain or chronic opioid use, or are actively taking a list of prohibited anti-inflammatory medications prior to the intervention will be excluded from the study. The list of prohibited anti-inflammatory medications includes ibuprofen, naproxen, diclofenac, and celecoxib. Patients who develop any Clavien grade complication postoperatively were will also be excluded.

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)
Simple randomisation using procedures like coin-tossing
and dice-rolling
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26720 0
Holmesglen Private Hospital - Moorabbin
Recruitment postcode(s) [1] 42759 0
3189 - Moorabbin

Funding & Sponsors
Funding source category [1] 316785 0
Self funded/Unfunded
Name [1] 316785 0
Self funded/Unfunded
Country [1] 316785 0
Primary sponsor type
Individual
Name
Yi Xie - Peninsula Health
Address
Country
Australia
Secondary sponsor category [1] 319007 0
None
Name [1] 319007 0
Address [1] 319007 0
Country [1] 319007 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315556 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315556 0
Ethics committee country [1] 315556 0
Australia
Date submitted for ethics approval [1] 315556 0
09/05/2024
Approval date [1] 315556 0
Ethics approval number [1] 315556 0

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

Contacts
Principal investigator
Name 135066 0
Dr Yi Xie
Address 135066 0
Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 135066 0
Australia
Phone 135066 0
+61416068801
Fax 135066 0
Email 135066 0
[email protected]
Contact person for public queries
Name 135067 0
Yi Xie
Address 135067 0
Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 135067 0
Australia
Phone 135067 0
+61416068801
Fax 135067 0
Email 135067 0
[email protected]
Contact person for scientific queries
Name 135068 0
Yi Xie
Address 135068 0
Frankston Hospital, 2 Hastings Road, Frankston VIC 3199
Country 135068 0
Australia
Phone 135068 0
+61416068801
Fax 135068 0
Email 135068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23909Informed consent form  [email protected]
23910Study protocol  [email protected]



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.