Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block

This study has suspended participant recruitment.
(Protocol amendment)
Sponsor:
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT01172197
First received: July 28, 2010
Last updated: July 29, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172197

Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: Graeme A McLeod, MD FRCA NHS Tayside
  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
Ropivacaine
Levobupivacaine
Bupivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2014