Contact information
Type
Scientific
Primary contact
Dr Vivienne Ng
ORCID ID
Contact details
North wales NHS Trust
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
+44 1745 583910
hyvng@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to compare analgesia and side effects of intrathecal fentanyl and intrathecal morphine
Acronym
Study hypothesis
Null hypothesis:
There is no difference in analgesic requirements in patients using 25 mcg fentanyl, 50 mcg morphine or 100 mcg of morphine intrathecally alongside 2.5 ml 0.5% heavy marcaine within the first 24 hours post operation.
Ethics approval
To be submitted to the North Wales (Central) Research Ethics Committee in March 2009 (ref: 09/WNo02/6).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please email ngvivienne@cd-tr.wales.nhs.uk to request a patient information sheet
Condition
Analgesia and anaesthesia in orthopaedic surgery
Intervention
The 90 patients will be randomised into 3 groups. The first group will be given 2.5 ml of heavy bupivacaine 0.5% with 25 mcg of fentanyl intrathecally, the second group will be given 2.5 ml of heavy bupivacaine 0.5% with 50 mcg of morphine intrathecally and the last group will be given 2.5 ml of heavy bupivacaine 0.5% with 100 mcg of morphine intrathecally.
To minimise operator factors, there will be one anaesthetist performing the anaesthesia. Intraoperatively, patients will be given 1 g paracetamol (intravenous).
The usage of vasopressors and fluids intraoperatively will be noted. Patients are observed postoperatively in high care and the usage of patient controlled analgesia (PCA) morphine as well as respiratory rates and other side effects will be monitored closely. Patients are only given paracetamol (intravenous) 1 g four times a day (qds) in the first 24 hours as well as the morphine PCA.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fentanyl, morphine
Primary outcome measure
Analgesic usage in first 24 hours.
Secondary outcome measures
The following will be monitored for the first 24 hours:
1. Vasopressors usage
2. Blood pressure (BP)
3. Respiratory rates
4. Side effects
Overall trial start date
01/05/2009
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, aged 18-100
2. American Society of Anesthesiologists (ASA) 1 and 2
3. Patients planned for an elective orthopaedic surgery needing spinal anaesthetic as part of routine anaesthetic management
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Children <18 years old
2. Pregnant women
3. Patients with contraindications to spinal anaesthetic
4. Patients unable to give informed consent
Recruitment start date
01/05/2009
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North wales NHS Trust
Denbighshire
LL18 5UJ
United Kingdom
Sponsor information
Organisation
North Wales NHS Trust (UK)
Sponsor details
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom
+44 (0)1745 583910
ngvivienne@cd-tr.wales.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Wales NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list