Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic - Full Text View

Purpose

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	Intervention	Phase
Pain Total Knee Arthroplasty	Drug: Dexamethasone Drug: Ropivacaine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Duration of Analgesia [ Time Frame: 72 hours or first report of pain in the knee which ever is earliest ] [ Designated as safety issue: No ]
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:

Duration of motor blockade [ Time Frame: 72 hour or first return of motor function ] [ Designated as safety issue: No ]
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
Duration of sensory blockade [ Time Frame: 72 hours or first report of sensory recovery ] [ Designated as safety issue: No ]
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
Complete sensory return [ Time Frame: 72 hours or when the patient first reports complete sensation ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	70
Study Start Date:	September 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511211

Contacts

Contact: Nicholas C Lam, MD	832-788-7789	nlam@salud.unm.edu
Contact: Timothy Petersen, PhD	505-272-1762	TimPetersen@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico Hospital	Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Timothy Petersen, PhD 505-272-1762 TimPetersen@salud.unm.edu
Principal Investigator: Nicholas Lam, MD
Sub-Investigator: Brian Starr, MD
Sub-Investigator: Tony Yen, MD
Sub-Investigator: Mary Billstrand, MD
Sub-Investigator: Nelson Guevara, MD
Sub-Investigator: John Draper, MD

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Nicholas Lam, MD

University of New Mexico

More Information

No publications provided

Responsible Party:	Nicholas Lam, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier:	NCT01511211 History of Changes
Other Study ID Numbers:	UNMLAMLLDEX
Study First Received:	January 12, 2012
Last Updated:	July 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by 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:

Anesthetics, Local
Ropivacaine
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013