Hamstrings graft donor site infiltration with bupivacaine for pain relief after arthroscopically assisted anterior cruciate ligament reconstruction

ISRCTN	ISRCTN75639135
DOI	https://doi.org/10.1186/ISRCTN75639135
Secondary identifying numbers	N0077186661

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 12/10/2017

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

Mr G Geutjens
Scientific

Derby Hospitals NHS Foundation Trust
Trauma & Orthopaedics Department
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Hamstrings graft donor site infiltration with bupivacaine for pain relief after arthroscopically assisted anterior cruciate ligament reconstruction
Study objectives	Does long acting local injected anaesthetic around the hamstrings in addition to femoral nerve block provide better post operative pain relief then femoral nerve block alone in patients having ACL reconstruction with the new ligament taken from their hamstrings tendon?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anterior cruciate ligament reconstruction
Intervention	On postoperative ward rounds it has been noted that patients often complain that they have pain I their hamstrings during the first 24 hours after surgery. After consultation with the anaesthetic department it has been proposed that the femoral nerve block currently administered for pain relief does not alleviate this pain sufficiently and a more localised infiltration to this area may be variable form person to person. To perform a block on each individual nerve would be impractical as their anatomy is variable and blocks to the obturator nerve are challenging procedure. A local infiltration (injection) at the site of pain is quick, easy and safe and should negate the need for this. Patients agreeing to take part will be randomly assigned to one of two groups, both of which will receive our current standard post-operative pain relief of femoral nerve block and oral pain killers. The first group (case) will also receive local anaesthetic into the hamstrings (0.375% bupivacaine) and the second group (control) will receive saline into the hamstrings.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure	Post operative pain scores in the region of the hamstrings
Secondary outcome measures	Not provided at time of registration
Overall study start date	29/08/2006
Completion date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	50
Key inclusion criteria	Patients having primary anterior cruciate ligament reconstruction with hamstrings ipsilateral hamstrings tendon graft, under spinal anaesthesia
Key exclusion criteria	1. Patients unwilling to participate 2. Those undergoing any procedure other than that described as inclusion criteria 3. Patients unable to consent for themselves 4. Patients with a known allergy to bupivacaine 5. Patients with peripheral neuropathy
Date of first enrolment	29/08/2006
Date of final enrolment	31/05/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE1 2QY
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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

12/10/2017: No publications found, verifying study status with principal investigator.