Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
23/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Duggan

ORCID ID

Contact details

Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0504163841

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Ropivacaine, bupivacaine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2005

Recruitment end date

01/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wansbeck General Hospital
Ashington
NE63 9JJ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Northumbria Healthcare 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes