Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077186661
Study information
Scientific title
Hamstrings Graft Donor Site Infiltration with Bupivacaine for Pain Relief after Arthroscopically Assisted Anterior Cruciate Ligament Reconstruction
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Anterior cruciate ligament reconstruction
Intervention
On post operative 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
Phase
Not Specified
Drug names
Bupivacaine
Primary outcome measures
Post operative pain scores in the region of the hamstrings
Secondary outcome measures
Not provided at time of registration
Overall trial start date
29/08/2006
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having primary anterior cruciate ligament reconstruction with hamstrings ipsilateral hamstrings tendon graft, under spinal anaesthesia.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant 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
Recruitment start date
29/08/2006
Recruitment end date
31/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
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
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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