Condition category
Surgery
Date applied
18/10/2006
Date assigned
07/11/2006
Last edited
25/04/2014
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 Maruthi S R R Ganugapenta

ORCID ID

Contact details

50,Milestone Close
Heath
Cardiff
CF14 4NQ
United Kingdom
+44 (0) 2920691036
reddymaruthi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.

Study information

Scientific title

Acronym

ITM vs PNB

Study hypothesis

To compare intrathecal morphine with peripheral nerve block for postoperative analgesia following unilateral primary total knee replacement.

Ethics approval

South East Wales Research Ethics Committee in February 2007 (ref: 06/WSE04/126)

Study design

Double blind randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Analgesia following total knee replacements

Intervention

Spinal Anaesthesia: A fine needle in the lower back. We will give 3 ml of 0.5% heavy Bupivacaine in one group and the same volume in the second group but combined with morphine 7 micrograms/Kg, maximum of 500 microgram.

Femoral 3 in 1 block: In the groin 30 ml of plain Bupivacaine 0.38% will be injected close to the Femoral nerve with a special locator needle. This is done in group one.

Sciatic nerve block: In the buttock 15 ml of 0.38% plain Bupivacaine will be injected close to the Sciatic nerve with the special locator needle.This is also done in group one.

Intervention type

Drug

Phase

Not Specified

Drug names

Intrathecal morphine, Tramadol

Primary outcome measures

The primary outcome measure is the quality of pain relief on movement of knee joint.

Secondary outcome measures

The secondary outcome measures include:
1. The number of patients requiring rescue analgesia
2. Time for the first dose of Tramadol
3. The incidence of the adverse effects of Morphine and Visual Analogue Scale (VAS) for patient satisfaction at 48 hours

Overall trial start date

01/01/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary elective total knee replacement
2. Fit patients of American Society of Anesthesiologists (ASA) classification one to three

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Patients who refuse consent
2. Revision surgery
3. Had adverse reaction or a contraindication to the administration of morphine, local anaesthetics, non-steroidal anti-inflammatory drugs, paracetamol, tramadol, centrineuraxial block and peripheral nerve blocks
4. Patient with history of chronic pain other than at the site of joint replacement
5. Used regular strong opioids
6. Renal impairment
7. Liver impairment
8. ASA physical status greater than three

Recruitment start date

01/01/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

50,Milestone Close
Cardiff
CF14 4NQ
United Kingdom

Sponsor information

Organisation

Gwent Healthcare NHS Trust (UK)

Sponsor details

c/o Ms Rosamund Howell
Postgraduate Centre
The Friars
Friars Road
Newport
NP20 4EZ
United Kingdom
+44 (0)1633 238138
Rosamund.howell@gwent.wales.nhs.uk

Sponsor type

Government

Website

http://www.wales.nhs.uk/sites3/home.cfm?OrgID=79

Funders

Funder type

Government

Funder name

Royal Gwent Hospital Trust Research and Development (Reg: RD/505/06) - No external funding is necessary

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