Evaluation of post-operative pain relief for local anaesthetic (LA) 0.5% Bupivacaine is administered to a patient prior to the closure of surgical wound for a distal forearm fracture using: Method 1. Injection of LA subcutaneously around the wound site, prior to wound closure, while the patient is under a general anaesthetic. or Method 2. Percolation of LA directly into wound cavity, prior to wound closure, while the patient is under a general anaesthetic. No needle used

Phase 1

• Conditions: Fracture of distal radius or ulna; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000229-35-IE
• Lead Sponsor: Beaumont Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 89

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified