Hyperbaric intra-thecal ropivacaine - a comparison with hyperbaric bupivacaine with respect to extent and duration of motor block

ISRCTN	ISRCTN36749569
DOI	https://doi.org/10.1186/ISRCTN36749569
Secondary identifying numbers	N0504163841

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 23/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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 John Duggan
Scientific

Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Hyperbaric intra-thecal ropivacaine - a comparison with hyperbaric bupivacaine with respect to extent and duration of motor block
Study objectives	1. Does intra-thecal hyperbaric ropivacaine result in motor block of shorter duration when compared with an equal dose of bupivacaine (of equal baricity and concentration)? 2. Furthermore, does intra-thecal hyperbaric ropivacaine produce a sensory block of similar extent and duration to an equal dose of intra-thecal bupivacaine of equal baricity and concentration?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	40 patients undergoing spinal anaethesia would be recruited to our study and randomised to receive equal hyperbaric doses of either 0.5% bupivacaine in 8% glucose solution or 0.5% ropivacaine in 8% glucose solution. The solutions would be of similar anaesthesia under standardised conditions, we would measure a number of parameters of particular interest. After surgery, we would study the recovery profile of all recruited subjects for the duration of time taken to achieve complete neurological recovery. We would record strength of dorsi-flexion in 15 minute intervals and time to regression of sensory block.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ropivacaine, bupivacaine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2005
Completion date	01/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Elective surgery 2. Patient and surgery appropriate for spinal anaesthesia 3. ASA grade <3 4. Age >18 years 5. Non-pregnant 6. No known sensitivities to amide class of local anaesthetics 7. Not currently or recently (<3 months) recruited to other clinical trials
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2005
Date of final enrolment	01/05/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wansbeck General Hospital

Ashington
NE63 9JJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Northumbria Healthcare 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