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This study has been withdrawn prior to enrollment.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
  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:


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
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
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

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: 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
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System 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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on September 16, 2014