| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75639135 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0077186661 |
| Public title | Hamstrings Graft Donor Site Infiltration with Bupivacaine for Pain Relief after Arthroscopically Assisted Anterior Cruciate Ligament Reconstruction |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Surgery: Anterior cruciate ligament reconstruction |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients having primary anterior cruciate ligament reconstruction with hamstrings ipsilateral hamstrings tendon graft, under spinal anaesthesia. |
| Participants - 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 |
| Patient information material |
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| Anticipated start date | 29/08/2006 |
| Anticipated end date | 31/05/2007 |
| Status of trial | Completed |
| Target number of participants | 50 |
| Interventions | 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. |
| Primary outcome measure(s) | Post operative pain scores in the region of the hamstrings |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Derby Hospitals NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr G Geutjens |
| Contact details | Derby Hospitals NHS Foundation Trust
Dept. Trauma & Orthopaedics
Derbyshire Royal Infirmary
London Road
Derby
United Kingdom
DE1 2QY |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75639135 |
| Date last extracted from ISRCTN register | 17/04/2008 |
