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Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic

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ClinicalTrials.gov Identifier: NCT01511211
Recruitment Status : Withdrawn (Other researchers have published results on a similar trial)
First Posted : January 18, 2012
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nicholas Lam, University of New Mexico

Study Description
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Brief Summary:
This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone to Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and popliteal block after total knee replacement surgery.

Condition or disease Intervention/treatment Phase
Pain Total Knee Arthroplasty Drug: Dexamethasone Drug: Ropivacaine Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dexamethasone on Duration of Analgesia After Ultrasound-Guided Femoral, Obturator, and Popliteal Blocks With Ropivacaine in Total Knee Arthroplasty
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ropivacaine + Dexamethasone Combination Drug: Dexamethasone
2 cc of 4 mg/cc dexamethasone will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for a femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of normal saline will be added to the patient's IV to maintain blinding.
Other Name: Decadron
Active Comparator: Ropivacaine-Only Block Drug: Ropivacaine
2 cc of normal saline will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for the femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of 4 mg/cc dexamethasone will be added to the patient's IV.
Other Name: Naropin


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Analgesia [ Time Frame: 72 hours or first report of pain in the knee which ever is earliest ]
    Duration of analgesia defined as the time interval between the end of local anesthetic injection and the patient's first report of pain in the knee.


Secondary Outcome Measures :
  1. Duration of motor blockade [ Time Frame: 72 hour or first return of motor function ]
    Time interval between the end of local anesthetic injection and the patient's first report of return in motor function in femoral, obturator and sciatic distribution

  2. Duration of sensory blockade [ Time Frame: 72 hours or first report of sensory recovery ]
    Time interval between the end of local anesthetic injection and the patient's first report of return in any sensation in the distribution of femoral and sciatic distribution

  3. Complete sensory return [ Time Frame: 72 hours or when the patient first reports complete sensation ]
    interval between the end of local anesthetic injection and the patient's first report of return in complete sensation in the distribution of femoral and sciatic distribution


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I to III,
  • Aged 18 and above,
  • Undergoing total knee replacement.

Exclusion Criteria:

  • Body mass index of more than 45 kg/m2 (higher chance of failure)
  • Weight less than 70 kg
  • Diabetes
  • Injection site deformities
  • Infection at the injection site
  • Existing peripheral neuropathy
  • Allergy to LA agents
  • Contraindications to dexamethasone
  • Patients with severe PONV
  • Patients with peptic ulceration or upper GI bleed of unknown origin
  • Coagulopathy
  • Any other contraindication to lower limb peripheral nerve block
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01511211


Locations
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Nicholas Lam, MD University of New Mexico
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nicholas Lam, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01511211     History of Changes
Other Study ID Numbers: UNMLAMLLDEX
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Nicholas Lam, University of New Mexico:
Dexamethasone
lower limb block
ultrasound guided femoral nerve block
ultrasound guided obturator nerve block
 ultrasound guided sciatic nerve block
ropivacaine
total knee arthroplasty
Post surgical pain after total knee arthroplasty

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents