ANZCTR - Registration

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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

Condition category

Condition code

Injuries and Accidents

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]

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]

Range of Movement

Timepoint [1]

At Day 1, 2 and Week 2, 4, 6, 12 post-op

Secondary outcome [1]

Time to discharge from hospital

Timepoint [1]

Secondary outcome [2]

Use of opioids in the postoperative period

Timepoint [2]

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]

Rate of wound infection

Timepoint [3]

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]

Patient satisfaction with the procedure and postoperative care.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Orthopaedics Princess Alexandra Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Ryan Shulman

Address

Country

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Princess Alexandra Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Ryan Shulman

Address

110 Ferndale St
Annerley
Brisbane QLD 4103

Country

Australia

Phone

+61 418986118

Fax

+61 7 3240 6355

info@umatology.com

Contact person for scientific queries

Name

Dr Ryan Shulman

Address

110 Ferndale St
Annerley
Brisbane QLD 4103

Country

Australia

Phone

+61 418986118

Fax

+61 7 3240 6355

info@umatology.com

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.

Trial Review

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