To compare analgesia and side effects of intrathecal fentanyl and intrathecal morphine

ISRCTN	ISRCTN49793641
DOI	https://doi.org/10.1186/ISRCTN49793641
Secondary identifying numbers	N/A

Submission date: 02/03/2009
Registration date: 27/03/2009
Last edited: 16/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vivienne Ng
Scientific

North wales NHS Trust
Bodelwyddan
Denbighshire
LL18 5UJ
United Kingdom

Phone	+44 1745 583910
Email	hyvng@doctors.org.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please email ngvivienne@cd-tr.wales.nhs.uk to request a patient information sheet
Scientific title	A randomised controlled trial to compare analgesia and side effects of intrathecal fentanyl and intrathecal morphine
Study objectives	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(s)	To be submitted to the North Wales (Central) Research Ethics Committee in March 2009 (ref: 09/WNo02/6).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2009
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	Both
Target number of participants	90
Key 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
Key exclusion criteria	1. Children <18 years old 2. Pregnant women 3. Patients with contraindications to spinal anaesthetic 4. Patients unable to give informed consent
Date of first enrolment	01/05/2009
Date of final enrolment	30/04/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

North wales NHS Trust

Denbighshire
LL18 5UJ
United Kingdom

Sponsor information

North Wales NHS Trust (UK)
Hospital/treatment centre

Bodelwyddan
Denbighshire
LL18 5UJ
Wales
United Kingdom

Phone	+44 (0)1745 583910
Email	ngvivienne@cd-tr.wales.nhs.uk
Website	http://www.wales.nhs.uk/sites3/home.cfm?orgid=802
"ROR"	https://ror.org/04a496k07

Funders

Funder type

Government

North Wales NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

16/06/2016: No publications found, verifying study status with principal investigator.