ANZCTR - Registration

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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]

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

dupuytren's disease

carpal tunnel syndrome

hand surgery

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

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]

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]

Total opioid analgesic consumption

Timepoint [1]

6 weeks postoperatively

Secondary outcome [1]

Time to first usage of opioid analgesia postoperatively

Timepoint [1]

baseline, 2, 4, 6 and 8 weeks postoperatively

Secondary outcome [2]

Subjective postoperative pain

Timepoint [2]

Baseline, 2, 4, 6 and 8 weeks postoperatively

Secondary outcome [3]

Hand function

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Holmesglen Private Hospital - Moorabbin

Recruitment postcode(s) [1]

3189 - Moorabbin

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Self funded/Unfunded

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Yi Xie - Peninsula Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

https://monashhealth.org/research/resources/resource-library/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This will be a pilot study to determine efficacy of combination clonidine, adrenaline, ropivacaine, lidocaine, dexamethasone combination in reducing pain, time to first opioid analgesia, and total opioid analgesia consumption postoperatively compared with combination lidocaine and ropivacaine. We hypothesise that the combination of the above medication will contribute to a longer lasting postoperative anaesthetic effect, such that patients will be more comfortable in the 24-48 hours post surgery, requiring less usage of opiate analgesia, and a quicker return to premorbid activity and function.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Yi Xie

Address

Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61416068801

Fax

philip.y.xie@gmail.com

Contact person for public queries

Name

Yi Xie

Address

Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61416068801

Fax

philip.y.xie@gmail.com

Contact person for scientific queries

Name

Yi Xie

Address

Frankston Hospital, 2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61416068801

Fax

philip.y.xie@gmail.com

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 (philip.y.xie@gmail.com)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23909	Informed consent form			philip.y.xie@gmail.com
23910	Study protocol			philip.y.xie@gmail.com

Results publications and other study-related documents

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