A prospective randomised control trial comparing local anaesthetic subcutaneous wound injection versus local anaesthetic wound percolation in distal forearm fractures

Beaumont Hospital0 个研究点目标入组 89 人开始时间: 2015年3月5日最近更新: 2019年12月10日

适应症

试验速览

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•-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

•-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

发起方

Beaumont Hospital