Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172197
Recruitment Status : Terminated (Terminated prior to its planned completion as anticipated by the protocol).)
First Posted : July 29, 2010
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
NHS Tayside

Brief Summary:

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 median effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after total knee replacement. Further, calculation of the equipotent median effective dose's of each local anaesthetic allied to objective measurement of quadriceps motor block using an electromyogram will allow us to determine the sensory - motor split of each local anaesthetic.

Condition or disease Intervention/treatment Phase
Pain Arthroplasty, Replacement, Knee Drug: Levobupivacaine Drug: Ropivacaine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Single Blind Study Comparing the Molar Median Effective Dose of Levobupivacaine and Molar Median Effective Dose of Ropivacaine When Administered as a Femoral Perineural Infusion for Pain Relief After Total Knee Replacement
Study Start Date : January 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain [ Time Frame: 30 hours ]
    Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01172197

Sponsors and Collaborators
NHS Tayside
Principal Investigator: Graeme A McLeod, MD FRCA NHS Tayside

Responsible Party: NHS Tayside Identifier: NCT01172197     History of Changes
Other Study ID Numbers: 2008-002136-15
2008-002136-15 ( EudraCT Number )
2008 AN02 ( Registry Identifier: NHS R&D )
08/S1402/30 ( Registry Identifier: East of Scotland Medical Ethics Committee )
24891/0009/001-0001 ( Registry Identifier: MHRA )
First Posted: July 29, 2010    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018
Last Verified: April 2018

Keywords provided by NHS Tayside:
local anesthetic
femoral perineural block

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents