Fracture of distal radius or ulna
Conditions
Interventions
Trade Name: Marcain Heavy Steripack, 0.5%w/v Solution for Injection
Product Name: Marcain Heavy Steripack, 0.5%w/v Solution for Injection
Pharmaceutical Form: Solution
Sponsors
Beaumont Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol - Subjects must be male or female, aged 18 -74 years - Diagnosed with a distal wrist fracture of the radius or ulna requiring a single incision for open reduction and internal fixation. - Subjects who are judged fit to undergo a general anaesthesia for operative treatment - Female subjects' urine pregnancy test performed at the screening period must be negative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 89 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Allergy/sensitivity to Bupivacaine - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. - Subjects who have participated in another study and received any other investigational agent within 30 days. - Subjects unable to provide written informed consent and unable to have witnessed consent to a mark provided by their non-dominant hand by a person not connected to the study - Subjects who have any other significant disease or disorder (including uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accident) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. - Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements. - Aged greater than 74 years - Aged less than 18 years - Distal wrist fracture radius and ulna requiring > 1 incision for open reduction and internal fixation - Increased volume of local anaesthetic (>10mls Bupivacaine Hydrochloride 0.5%w/v Solution for Injection, advised to be administered as per the discretion of the anaesthetist or surgeon during the treatment period for the benefit of the study participant. - In receipt of regularly prescribed opiates for pain other than their current injury - Pregnant Women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Evaluation of post-operative pain scores at 3, 6 & 12 hours using the Visual Analogue Scale* and comparison of the outcomes of both treatment arms to assess for a statistical significance. 2. Retrospective audit of opiate consumption in the 12 hours post operatively and comparison of the outcomes of both treatment arms to assess for a statistical significance. ; Secondary Objective: 1. Completion of a psychological assessment(s) e.g STAI, pre operatively to assess predisposing personality traits and compare to the results of pain scores & opiate consumption (Primary Objectives 1&2) 2. Retrospective analysis of cost difference and potential cost saving. 3. Assessment of any potential risk reduction of needle stick injury. ; Primary end point(s): 1.Mean clinically important difference in pain as per VAS Scores in LA percolation arm compared to LA subcutaneous injection arm. 2.Increased frequency of requirement for opiates in the LA percolation arm compared to the LA subcutaneous injection arm. ; Timepoint(s) of evaluation of this end point: 1. At 3, 6 & 12 hours post operatively 2. Consecutive 12 hours post operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Reduced cost or equal direct cost of giving local anaesthetic solution 2. Higher levels of anxiety experienced by participants across both treatment arms in patients requiring more PRN analgesia and experiencing greater pain using VAS 3. Absolute avoidance of needle stick injury to deliver local anaesthetic. ; Timepoint(s) of evaluation of this end point: 1. At time of treatment 2. Post completion of inventory & retrospective review of opiate consumption and VAS 3. At time of treatment | — |
Countries
Ireland
Contacts
Public ContactLaura Ann Lambert
Beaumont Hospital
Outcome results
None listed