Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000450516
Ethics application status
Not yet submitted
Date submitted
9/04/2006
Date registered
18/10/2006
Date last updated
18/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuous Infusion Analgesia in Post Surgical Distal Radial Fractures
Scientific title
Range of Motion, Time to Discharge, Postoperative Opioid Use, Wound Infection Rate and Patient satisfaction Post Continuous Infusion of Ropivacaine After Internal Fixation of Distal Radial Fractures With Tri-Med Stabilisation System
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unstable Distal Radial Fracture 1423 0
Condition category
Condition code
Injuries and Accidents 1520 1520 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ropivacaine hydrochloride 10mL 0.75% initial bolus dose given to both treatment and control groups via fenestrated catheters in each surgical wound.
Treatment group receives: continuous infusion of ropivacaine 0.2% into the wound, running at 2ml/hr for 48 hours via the fenestrated catheter.

Baseline analgesia for both groups:
Paracetamol (1g QID oral) for 4 days.
Break through pain relief: oxycodone (5-10mg q3h PRN oral) and / or subcutaneous morphine (2.5 – 5mg q3h PRN) for 4 days. Patient’s who are allergic to oxycodone or morphine will be prescribed an appropriate alternative by the treating surgeon.
Additional oral analgesia may be provided on discharge to patients if required and will be a continuation of the baseline analgesia provided to both groups - this will will be provided to last until the patient's first follow-up appointment at 2 weeks.
Intervention code [1] 975 0
Treatment: Drugs
Comparator / control treatment
Control group receives Normal Saline 0.9% in the wound, running at 2ml/hr for 48 hours via the fenestrated catheter.
Control group
Placebo

Outcomes
Primary outcome [1] 2099 0
Range of Movement
Timepoint [1] 2099 0
At Day 1, 2 and Week 2, 4, 6, 12 post-op
Secondary outcome [1] 3630 0
Time to discharge from hospital
Timepoint [1] 3630 0
Secondary outcome [2] 3631 0
Use of opioids in the postoperative period
Timepoint [2] 3631 0
Measured on Day 1 & 2 post operation as well as at 2, 4, 6, 12 week periods. Follow-up would end at the 3 month period.
Secondary outcome [3] 3632 0
Rate of wound infection
Timepoint [3] 3632 0
Measured on Day 1 & 2 post operation as well as at 2, 4, 6, 12 week periods. Follow-up would end at the 3 month period.
Secondary outcome [4] 3633 0
Patient satisfaction with the procedure and postoperative care.
Timepoint [4] 3633 0
Measured on Day 1 & 2 post operation as well as at 2, 4, 6, 12 week periods. Follow-up would end at the 3 month period.

Eligibility
Key inclusion criteria
Consenting patients with unstable distal radial fractures requiring surgical/internal fixation using the Tri-Med plating system.
Minimum age
14 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients allergic to ropivacaine; pregnant women (ropivacaine is a B1 drug).

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)
Sequentially numbered sealed envelopes controlled by pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2006
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)

Funding & Sponsors
Funding source category [1] 1655 0
Hospital
Name [1] 1655 0
Department of Orthopaedics Princess Alexandra Hospital
Country [1] 1655 0
Australia
Primary sponsor type
Individual
Name
Dr Ryan Shulman
Address
Country
Secondary sponsor category [1] 1463 0
None
Name [1] 1463 0
Nil
Address [1] 1463 0
Country [1] 1463 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3103 0
Princess Alexandra Hospital
Ethics committee address [1] 3103 0
Ethics committee country [1] 3103 0
Australia
Date submitted for ethics approval [1] 3103 0
Approval date [1] 3103 0
Ethics approval number [1] 3103 0

Summary
Brief summary
Fractures of the forearm can be managed conservatively in plaster casts if are simple and stable in nature. However, more unstable fractures require surgery and internal fixation using plates and screws. Post-operatively pain can limit movement and ultimately the duration of which functional limitations persist.
Currently, post-operative analgesia involves, administration via the bloodstream (intravenous), into the skin (subcutaneous) and orally. We would like to assess the potential benefits (improved pain control and earlier functional return) of using a low dose infusion of local anaesthetic into the surgical wound site.
We would like to recruit participants for the study from the group patients with these injuries that come through the PA Hospital Emergency Department. Our aim is to use 40 participants. Twenty of whom will receive an infusion of ropivacaine - a local anaesthetic (treatment group) and twenty who will receive an infusion of normal saline (placebo group). Patients will be blinded to their allocation to either group. The participants will be identified by orthopaedic consultants, registrars and residents. These patients will receive an information sheet and the written consent will be required for their participation.
A written data collection form will include the following fields: Range of motion; Time to discharge from hospital; Use of other analgesia in the postoperative period; Rate of wound infection; Patient satisfaction with the procedure and postoperative care. This will be completed by the hand therapists from the orthopaedic department on the wards and at subsequent follow-up therapy sessions based on their rehabilitation protocol. This is standard data that is collected by therapists and should not be of inconvenience.

Once data is collected we will analyse the data for any statistically significant variations in long or short term post-operative recovery between treatment and placebo groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36347 0
Address 36347 0
Country 36347 0
Phone 36347 0
Fax 36347 0
Email 36347 0
Contact person for public queries
Name 10164 0
Dr Ryan Shulman
Address 10164 0
110 Ferndale St
Annerley
Brisbane QLD 4103
Country 10164 0
Australia
Phone 10164 0
+61 418986118
Fax 10164 0
+61 7 3240 6355
Email 10164 0
[email protected]
Contact person for scientific queries
Name 1092 0
Dr Ryan Shulman
Address 1092 0
110 Ferndale St
Annerley
Brisbane QLD 4103
Country 1092 0
Australia
Phone 1092 0
+61 418986118
Fax 1092 0
+61 7 3240 6355
Email 1092 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.