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Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01971645
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : March 20, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Giorgio Veneziano, Nationwide Children's Hospital

Brief Summary:
If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2 mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.

Condition or disease Intervention/treatment Phase
Knee Injury Drug: Dexamethasone Drug: Ropivacaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Group D
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Drug: Dexamethasone
Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.

Drug: Ropivacaine
Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.

Placebo Comparator: Group R
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Drug: Ropivacaine
Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.

Active Comparator: Group M
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Drug: Dexamethasone
Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.

Drug: Ropivacaine
Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.




Primary Outcome Measures :
  1. Intra-operative and Post-operative Opioid Consumption [ Time Frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours ]
    Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.


Secondary Outcome Measures :
  1. Post-operative Pain Scores [ Time Frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours ]
    Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children older than 10, and younger than 19 years of age undergoing unilateral arthroscopic surgery of the knee
  • American Society of Anesthesiologists (ASA) Status I or II
  • Patient's parent/guardian willing and able to give consent
  • Patient willing to give assent

Exclusion Criteria:

  • Arthroscopic anterior cruciate ligament repair
  • Systemic steroid use within the last 3 months
  • Diabetes mellitus
  • Females testing positive for pregnancy
  • BMI > 98th percentile
  • Positive pregnancy test
  • Coagulopathy
  • Renal or hepatic disease
  • Pre-existing motor or sensory deficits in the lower extremities
  • Predisposition for falls based on pre-existing sensory or motor deficits of the legs or inability to perform crutch training.
  • Non-English speaking
  • Systemic fungal infection
  • Immunosuppressed patients

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): NCT01971645


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Giorgio Veneziano, MD Nationwide Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giorgio Veneziano, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01971645    
Other Study ID Numbers: IRB13-00610
First Posted: October 29, 2013    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Keywords provided by Giorgio Veneziano, Nationwide Children's Hospital:
Dexamethasone
Ropivacaine
Knee arthroscopy
Femoral nerve blocks
Peripheral nerve blocks
Adjuvant
Pediatrics
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries
Dexamethasone
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents