Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block
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Purpose
The anaesthetic management of patients undergoing total knee replacement is still not standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting. Combined single injection femoral / sciatic blocks give good pain relief, but for a variable length of time (between 12 and 24 hours).
In contrast, continuous femoral perineural infusion of local anaesthetic provides very good pain relief for several days. Pain relief is maintained by a constant infusion of local anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full mobilisation within 24 hours Given that ropivacaine may offer a more advantageous pharmacological profile (less lipid solubility) compared to levobupivacaine, the investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain relief after surgery. Thus, the investigators aim in this study is to compare the ED50 of levobupivacaine with the ED50 of ropivacaine for preventive pain relief after total knee replacement. Further, calculation of the equipotent ED50's of each local anaesthetic allied to objective measurement of quadriceps motor block using an electromyogram (EMG) will allow us to determine the sensory - motor split of each local anaesthetic.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Arthroplasty, Replacement, Knee |
Drug: Levobupivacaine Drug: Ropivacaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Single Blind Study Comparing the Molar ED50 of Levobupivacaine and Molar ED50 of Ropivacaine When Administered as a Femoral Perineural Infusion for Pain Relief After Total Knee Replacement |
- Pain score [ Time Frame: 30 hours ] [ Designated as safety issue: No ]Pain on movement of knee
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ropivacaine
Local anaesthetic bolus and infusion
|
Drug: Levobupivacaine
Femoral bolus 150μM followed by femoral infusion 400μM
Other Name: Chirocaine
|
|
Active Comparator: Levobupivacaine
Local anaesthetic bolus and infusion
|
Drug: Ropivacaine
Bolus and infusion
Other Name: Naropin
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients >18 years of age and non pregnant presenting for elective knee replacement
Exclusion Criteria:
- Signs of cardiac failure (3rd heart sound, lung crepitations)
- Type I and type II diabetes
- Abnormal cardiac arrhythmias
- Hypovolaemia
- Presence of seizures,
- Dementia,
- Depression
- Encephalopathy,
- Terminal illness with a life expectancy < 3 months
- Age < 18 years
- Pregnant
- Coagulopathy INR>1.5
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Dr Andrew Russell, Medical Director, NHS Tayside |
| ClinicalTrials.gov Identifier: | NCT01172197 History of Changes |
| Other Study ID Numbers: | 2008-002136-15, 2008-002136-15, 2008 AN02, 08/S1402/30, 24891/0009/001-0001 |
| Study First Received: | July 28, 2010 |
| Last Updated: | July 29, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by NHS Tayside:
|
local anesthetic levobupivacaine ropivacaine femoral perineural block |
Additional relevant MeSH terms:
|
Anesthetics, Local Ropivacaine Levobupivacaine Bupivacaine Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013