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This study has been withdrawn prior to enrollment.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:
University of New Mexico
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
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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:
Drug Information available for:
Dexamethasone
Dexamethasone sodium phosphate
Dexamethasone acetate
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
| 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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01511211
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 |
| 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:
|
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate 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 September 23, 2016