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

ISRCTN	ISRCTN60588943
DOI	https://doi.org/10.1186/ISRCTN60588943
Clinical Trials Information System (CTIS)	2006-001580-30
Protocol serial number	N0202183594
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Royal Cornwall Hospitals NHS Trust

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

Mr Darren Fern
Scientific

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom

Phone	+44 (0)1872 253434
Email	Darren.Fern@rcht.cornwall.nhs.uk

Primary study design	Interventional
Study design	Prospective, randomised, double blind trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	steroid and local anaesthetic
Primary outcome measure(s)	Volume of morphine administered by PCA post op.
Key secondary outcome measure(s)	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
Completion date	31/10/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key 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.
Key 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
Date of first enrolment	03/08/2006
Date of final enrolment	31/10/2006

Royal Cornwall Hospitals NHS Trust

Truro
TR1 3LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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