The use of intrathecal morphine for post-operative pain relief following major abdominal surgery - the comparison of two doses (10 micrograms/kg and 20 micrograms/kg) medical condition = post-operative pain
Conditions
Interventions
Trade Name: Preservative free isotonic morphine
Product Name: Preservative free isotonic morphine
Pharmaceutical Form: Solution for injection
Sponsors
UHCW NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The teaching hospital in Coventry is a tertiary referral centre with 900 beds and serves a population of 500,000. The subjects of the study will be patients undergoing major abdominal surgery related to either the vascular system or gastro-intestinal tract. A total of 100 patients will be recruited into the trial. The age range will be 30 to 80 years with no exclusion related to gender. Bias will be controlled by including all patients of all surgeons involved with this type of surgery. This should ensure that patients are representative of the general population undergoing this type of surgery. Patients will be randomly allocated to one of two groups – 50 will receive 10 micrograms intrathecal morphine per kilogram body weight (to a maximum of 1mg) and 50 will receive 20 micrograms intrathecal morphine per kilogram body weight (to a maximum of 2mg). 100 envelopes (50 with 10 micrograms/kg and 50 with 20 micrograms/kg) will be used and the anaesthetist involved with the patient will select one sealed envelope randomly. The study should take between six and twelve months. Surgeons and anaesthetists involved in the trial will be given an information pack related to the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients excluded will be those who do not consent, those with clotting abnormalities, systemic infection, those with localised infection of the skin in the lumbar region and women who are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal dose for intrathecal morphine in major abdominal surgery for adults;Secondary Objective: To evaluate the efficacy of each dose in terms of side effects compared with analgesic effect;Primary end point(s): Completion of 100 patients and their data collection | — |
Countries
United Kingdom
Outcome results
None listed