Postoperative analgesia for total knee replacement: a comparison between intrathecal morphine and peripheral nerve blocks

ISRCTN	ISRCTN53794597
DOI	https://doi.org/10.1186/ISRCTN53794597
Secondary identifying numbers	1.

Submission date: 18/10/2006
Registration date: 07/11/2006
Last edited: 07/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Contact information

Dr Maruthi S R R Ganugapenta
Scientific

50,Milestone Close
Heath
Cardiff
CF14 4NQ
United Kingdom

Phone	+44 (0) 2920691036
Email	reddymaruthi@yahoo.com

Study information

Study design	Double blind randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Postoperative analgesia for total knee replacement: a comparison between IntraThecal Morphine and Peripheral Nerve Blocks
Study acronym	ITM vs PNB
Study objectives	The aim of this study is to compare intrathecal morphine with peripheral nerve block for postoperative analgesia following unilateral primary total knee replacement.
Ethics approval(s)	South East Wales Research Ethics Committee, February 2007, ref: 06/WSE04/126
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Intrathecal morphine, Tramadol
Primary outcome measure	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 study start date	01/01/2007
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	1. Primary elective total knee replacement 2. Fit patients of American Society of Anesthesiologists (ASA) classification one to three
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

50,Milestone Close

Cardiff
CF14 4NQ
United Kingdom

Sponsor information

Gwent Healthcare NHS Trust (UK)
Hospital/treatment centre

c/o Ms Rosamund Howell
Postgraduate Centre
The Friars
Friars Road
Newport
NP20 4EZ
Wales
United Kingdom

Phone	+44 (0)1633 238138
Email	Rosamund.howell@gwent.wales.nhs.uk
Website	http://www.wales.nhs.uk/sites3/home.cfm?OrgID=79
"ROR"	https://ror.org/045gxp391

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

07/03/2017: No publications found in PubMed, verifying study status with principal investigator