Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic

This study has been withdrawn prior to enrollment.

(Other researchers have published results on a similar trial)

Sponsor:

Information provided by (Responsible Party):

Nicholas Lam, University of New Mexico

ClinicalTrials.gov Identifier:

NCT01511211

First received: January 12, 2012

Last updated: September 11, 2013

Last verified: September 2013

History of Changes

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 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

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

U.S. FDA Resources

Further study details as provided by Nicholas Lam, 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 ]
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 ]
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 ]
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 ]
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


Enrollment:	0
Study Start Date:	September 2012
Study Completion Date:	August 2013
Primary Completion Date:	August 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 (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

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: 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


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:	September 11, 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 BB 1101 Ropivacaine 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

ClinicalTrials.gov processed this record on August 21, 2017

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