Morphine in simulated haemorrhagic shock
Research type
Research Study
Full title
Effects of morphine on the cardiovascular response to simulated haemorrhage and injury
IRAS ID
23626
Contact name
Jeremy Henning
Contact email
Sponsor organisation
South Tees Hospitals NHS FT
Eudract number
2010-020308-31
Duration of Study in the UK
11 years, 5 months, 7 days
Research summary
Does morphine delay the point of decompensation (blood pressure fall / fainting) during simulated haemorrhage and injury in healthy adult volunteers?
Morphine is widely used to control pain in trauma casualties. Other effects of morphine, such as cardiovascular effects, are the subject of opinion rather than evidence. There is no data to predict the action of morphine on the cardiovascular system following haemorrhage and injury. There is conflicting data from animal studies following haemorrhage with data from rats and sheep giving opposing findings. The study is important to help clinicians assess injured casualties who have been given morphine and help identify which animal models are most appropriate to comprehensively assess the potential deleterious side-effects of analgesic drugs.
The study is a prospective randomised controlled trial on healthy young adult volunteers. It will be conducted at James Cook University Hospital. Haemorrhage will be simulated using an established non-invasive technique called ‘lower body negative pressure’ (LBNP). During the test the volunteer will reach the point of fainting (decompensation or pre-syncope), when the test is terminated. The test is not uncomfortable. The test will be repeated twice (minimum 7 days apart), once with and once without morphine. The whole process will be repeated in a further group where injury will be simulated using an established technique where tourniquets (tight ‘bandages’) are applied around the legs. This will involve some discomfort but no lasting harm, which will be explained to the volunteers. The risk of clotting problems is minimised by including only low-risk individuals (healthy volunteers with no history of cardiovascular/clotting problems).
The measurements (e.g blood pressure, tissue oxygenation) will be non-invasive except for venous pressure (needle/cannula in a vein of the arm) and blood sampling (2 samples of 5 ml). Individuals may take part in both tourniquet and no-tourniquet studies and will therefore attend on 4 occasions. Similar measurements will be made during the pilot phase but this will involve one session and no use of morphine. The study is funded by the Ministry of Defence.
REC name
North East - York Research Ethics Committee
REC reference
10/H0903/38
Date of REC Opinion
24 Mar 2011
REC opinion
Further Information Favourable Opinion