Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/10/2016
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

Mr Darren Fern

ORCID ID

Contact details

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom
+44 (0)1872 253434
Darren.Fern@rcht.cornwall.nhs.uk

Additional identifiers

EudraCT number

2006-001580-30

ClinicalTrials.gov number

Protocol/serial number

N0202183594

Study information

Scientific title

Investigation into the effects of steroid and local anaesthetic infiltration into soft tissues in total hip replacement wounds on post-operative pain relief

Acronym

Study hypothesis

1. What are the effects on pain relief after total hip replacement of injecting steroid and local anaesthetic into hip wounds at operation?
2. Does the above have an effect on amount of morphine required postoperatively, the time taken to walk after operation, the total time spent in hospital and the rate of infection?

Ethics approval

Not provided at time of registration

Study design

Prospective, randomised, double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

The study will be a prospective, randomised, double blind trial comparing outcomes of three treatment groups:
1. Local anaesthetic only
2. Local anaesthetic and steroid
3. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

steroid and local anaesthetic

Primary outcome measures

Volume of morphine administered by PCA post op.

Secondary outcome measures

1. Visual analogue pain scores
2. Time to first dose of morphine
3. Time to mobilisation
4. Time to discharge
5. Complications ie delayed wound healing, dehiscence

Overall trial start date

03/08/2006

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing primary total hip replacement surgery for osteoarthritis will be selected for the trial from the waiting lists of two orthopaedic surgeons using the same prostheses.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Patients who are on regular steroid treatment
2. Those taking strong opioid analgesia regularly
3. Patients who are diabetic
4. In addition, patients with a history of peptic ulcer disease will be excluded as steroid treatment is contraindicated with this condition

Recruitment start date

03/08/2006

Recruitment end date

31/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

Not defined

Website

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

Funders

Funder type

Government

Funder name

Royal Cornwall Hospitals NHS Trust

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

24/10/2016: No publications found, verifying study status with principal investigator