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 |
| Protocol serial number | N0077186661 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Derby Hospitals NHS Foundation Trust
Trauma & Orthopaedics Department
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure(s) |
Post operative pain scores in the region of the hamstrings |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/10/2017: No publications found, verifying study status with principal investigator.
