None listed
Conditions
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.
Interventions
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 w
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.
Sponsors
Dr Ryan Shulman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Consenting patients with unstable distal radial fractures requiring surgical/internal fixation using the Tri-Med plating system.
Exclusion criteria
Patients allergic to ropivacaine; pregnant women (ropivacaine is a B1 drug).
Outcome results
None listed