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Knee InjuryPhase 3NCT01971645

Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

A Phase 3 study testing Dexamethasone and Ropivacaine in people with Knee Injury, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 10 to 19 years
Conditions the study is for
Knee Injury
What is being tested?
Dexamethasone and Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
1 siteUnited States
Study dates
Jul 2014to Sep 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy

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%.

Read the detailed description

Following informed consent, patients will be randomized to one (1) of three (3) arms. 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). 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). 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). The randomization will be blinded to the patient, surgery team, anesthesia team, recovery nurses, and clinical research nurses.

The remainder of the anesthetic care will remain the same per our usual routine for these cases. On arrival to the operating room:

  1. Standard American Society of Anesthesiologists (ASA) monitors will be placed on the patient (ECG, pulse oximetry, non-invasive BP, thermistor).
  2. A peripheral intravenous catheter will be placed while patient is inhaling 50% nitrous oxide.
  3. Intravenous induction will be accomplished with midazolam 2 mg, propofol 2-3 mg/kg.
  4. Once induction is complete, a laryngeal mask airway will be placed.
  5. Maintenance of anesthesia will be provided with inhaled sevoflurane titration.
  6. The femoral nerve block will be performed by one of the anesthesiologist co-investigators.
  7. After completion of a pre-block time-out, the patient's groin on side of surgery will be prepped with chlorhexidine.
  8. Using aseptic technique, a needle will be advanced under ultrasound guidance to the femoral nerve.
  9. In addition to ultrasound, a nerve stimulator may be used at the anesthesiologist's discretion to help identify the femoral nerve.
  10. After identification of the femoral nerve, the perineural study drug will be injected around the femoral nerve.
  11. Using aseptic technique the intramuscular study drug will be injected into the gluteus muscle.
  12. For intraoperative increases in heart rate or systolic blood pressure >20 % above levels immediately prior to incision, fentanyl will be given in 1 µg/kg increments every 5 minutes until below this threshold. (No acetaminophen, ketorolac, or IV dexamethasone will be given)
  13. Once the patient arrives to PACU, dilaudid 5 µg/kg (max. dose 0.3 mg) every ten minutes may be given until patient VAS score is less than or equal to 4.
  14. In the surgery unit, patients may receive one dose of hydrocodone-acetaminophen (7.5 mg/325 mg/15 ml) liquid suspension 0.1 mg/kg hydrocodone PO (max. dose 10mg hydrocodone) and then may receive dilaudid 5 µg/kg IV if pain persists above a VAS of 4 (max. dose 0.3 mg).
  15. Patients will be discharged from the surgery unit with a prescription for hydrocodone-acetaminophen (7.5 mg/325 mg/15 ml) liquid suspension. The prescription will be for 0.1 mg/kg hydrocodone PO (max. dose 10 mg hydrocodone) every 4 hours as needed for all patients.
  16. Patients will be sent home with a pain diary to record consumption of pain medication, when 1st dose of pain medications was taken, when sensory and motor blocks resolved and degree of motor block 24 and 48 hours according to the Bromage scale (Table 1). All adverse effects including nausea, vomiting, pruritus, excessive sedation will be asked to be recorded in the diary.
  17. A clinical research nurse will collect information on opioid consumption on day of surgery (DOS) and intensity of motor block in PACU according to the Bromage scale.
  18. On post-operative day 1 and 2 a clinical research nurse will call to collect information from the diary for analysis. If sensory or motor blockade persists on day 2, then the patient will be called on day 3. If neurologic symptoms persist after 72 hours, the patient will be asked to come to pre-operative clinic for a neurologic examination by an anesthesiologist. If neurological deficits are present on exam, the patient will be referred to a neurologist. Neurology will then determine if further testing is required. In addition, all patients will be contacted by telephone at 2 weeks after study initiation. If any new neurologic deficits are reported at this time, patients will be brought into the preoperative clinic and undergo the same evaluations.
Conditions
Knee Injury
Keywords
Dexamethasone, Ropivacaine, Knee arthroscopy, Femoral nerve blocks, Peripheral nerve blocks, Adjuvant, Pediatrics
Medical subject headings
Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.

  • RopivacaineDrug

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

Study groups in NCT01971645
Study groupRoleWhat they receive
Group DExperimentalGroup 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).
Receives: Drug: Dexamethasone; Drug: Ropivacaine
Group RPlacebo comparatorGroup 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).
Receives: Drug: Ropivacaine
Group MActive comparatorGroup 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).
Receives: Drug: Dexamethasone; Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra-operative and Post-operative Opioid Consumption

    Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.

    Measured: Intra-operative and up to 48 hours post-discharge, an average of 48 hours

Secondary outcomes (1)
  1. Post-operative Pain Scores

    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.

    Measured: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971645
Sponsor's protocol ID
IRB13-00610
Status last verified
Nov 2018
First submitted
22 Oct 2013
Last updated
11 Dec 2018
Data monitoring committee
Yes

Publications

  • Veneziano G, Martin DP, Beltran R, Barry N, Tumin D, Burrier C, Klingele K, Bhalla T, Tobias JD. Dexamethasone as an Adjuvant to Femoral Nerve Block in Children and Adolescents Undergoing Knee Arthroscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Reg Anesth Pain Med. 2018 May;43(4):438-444. doi: 10.1097/AAP.0000000000000739.

    PubMed 29377866

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone and Ropivacaine in people with Knee Injury, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-operative and Post-operative Opioid Consumption (time frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971645, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.

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