Condition category
Musculoskeletal Diseases
Date applied
02/03/2009
Date assigned
27/03/2009
Last edited
16/06/2016
Prospective/Retrospective
Prospectively 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 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 measures

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

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

http://www.wales.nhs.uk/sites3/home.cfm?orgid=802

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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