Open Reduction Internal Fixation(ORIF) of Lateral Malleolus Clinical Trial
Official title:
Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study
| Verified date | December 2013 |
| Source | Cork University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ireland: Research Ethics Committee |
| Study type | Interventional |
Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a better safety profile as the injection of local anaesthetic is performed under direct vision. This has allowed a reduction of the amount of local anaesthetic injected as compared to peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but of a consistently shorter duration compared to a long acting local anaesthetic alone. We hypothesize that sequential perineural injection of lidocaine and bupivacaine provides similar onset but a longer duration of sensory block compared to the same dose and volume of local anaesthetic mixed in advance.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients with ASA 1 - 3 status - scheduled to undergo semi-elective ankle/foot surgery under regional anaesthesia +/- sedation/opioid free general anaesthesia will be recruited Exclusion Criteria: - Patients having surgery on the medial aspect of the ankle/ foot - allergy to local anaesthetics - coagulopathy - malignancy or infection in the popliteal area - significant peripheral neuropathy - neurologic disorder of the lower extremity - any other contraindication to sciatic nerve block - pregnancy - history of alcohol or drug dependency/abuse (defined as >40 IU/week) - a history of significant cognitive or psychiatric disorder that may affect patient assessment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Cork University Hospital | Cork |
| Lead Sponsor | Collaborator |
|---|---|
| Cork University Hospital |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative analgesia/duration of block | 24 hours | No | |
| Secondary | onset of block | the block will be assessed every 5 minutes from the time of needle withdrawal till complete loss of sensation to touch. | 40 minutes | No |