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.
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
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:
- Standard American Society of Anesthesiologists (ASA) monitors will be placed on the patient (ECG, pulse oximetry, non-invasive BP, thermistor).
- A peripheral intravenous catheter will be placed while patient is inhaling 50% nitrous oxide.
- Intravenous induction will be accomplished with midazolam 2 mg, propofol 2-3 mg/kg.
- Once induction is complete, a laryngeal mask airway will be placed.
- Maintenance of anesthesia will be provided with inhaled sevoflurane titration.
- The femoral nerve block will be performed by one of the anesthesiologist co-investigators.
- After completion of a pre-block time-out, the patient's groin on side of surgery will be prepped with chlorhexidine.
- Using aseptic technique, a needle will be advanced under ultrasound guidance to the femoral nerve.
- In addition to ultrasound, a nerve stimulator may be used at the anesthesiologist's discretion to help identify the femoral nerve.
- After identification of the femoral nerve, the perineural study drug will be injected around the femoral nerve.
- Using aseptic technique the intramuscular study drug will be injected into the gluteus muscle.
- 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)
- 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.
- 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).
- 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.
- 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.
- 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.
- 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
- Being tested
- Dexamethasone, Ropivacaine
- 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 group | Role | What they receive |
|---|---|---|
| Group D | Experimental | 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). Receives: Drug: Dexamethasone; Drug: Ropivacaine |
| Group R | Placebo comparator | 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). Receives: Drug: Ropivacaine |
| Group M | Active comparator | 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). Receives: Drug: Dexamethasone; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted29 Oct 2013 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee InjuryStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Veneziano, Nationwide Children's Hospital
- Investigators
- Giorgio Veneziano, MD, Principal investigator, Nationwide Children's Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01971645
- Acronym / sponsor ID
- IRB13-00610
- Conditions
- Knee Injury
- Keywords
- Dexamethasone, Ropivacaine, Knee arthroscopy, Femoral nerve blocks, Peripheral nerve blocks, Adjuvant, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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:
- Standard American Society of Anesthesiologists (ASA) monitors will be placed on the patient (ECG, pulse oximetry, non-invasive BP, thermistor).
- A peripheral intravenous catheter will be placed while patient is inhaling 50% nitrous oxide.
- Intravenous induction will be accomplished with midazolam 2 mg, propofol 2-3 mg/kg.
- Once induction is complete, a laryngeal mask airway will be placed.
- Maintenance of anesthesia will be provided with inhaled sevoflurane titration.
- The femoral nerve block will be performed by one of the anesthesiologist co-investigators.
- After completion of a pre-block time-out, the patient's groin on side of surgery will be prepped with chlorhexidine.
- Using aseptic technique, a needle will be advanced under ultrasound guidance to the femoral nerve.
- In addition to ultrasound, a nerve stimulator may be used at the anesthesiologist's discretion to help identify the femoral nerve.
- After identification of the femoral nerve, the perineural study drug will be injected around the femoral nerve.
- Using aseptic technique the intramuscular study drug will be injected into the gluteus muscle.
- 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)
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: Dexamethasone, Drug: RopivacaineGroup 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 | Placebo comparator | Drug: RopivacaineGroup 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 | Active comparator | Drug: Dexamethasone, Drug: RopivacaineGroup 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). |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Arthroscopic anterior cruciate ligament repair
- Systemic steroid use within the last 3 months
- Diabetes mellitus
- Females testing positive for pregnancy
- BMI > 98th percentile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasonePatients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly. | Drug | Group D, Group M |
| RopivacainePatients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally. | Drug | Group D, Group M, Group R |
Primary outcome
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.
1 secondary outcome
Post-operative Pain Scores
Time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29377866Veneziano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Veneziano, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
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.