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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Knee Injury | Drug: Dexamethasone Drug: Ropivacaine | Phase 3 |

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. |
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Giorgio Veneziano, MD | Nationwide Children's Hospital |
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 |
Dexamethasone Ropivacaine Knee arthroscopy Femoral nerve blocks |
Peripheral nerve blocks Adjuvant Pediatrics |
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 |