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Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

Primary Purpose

Knee Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Ropivacaine
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injury focused on measuring Dexamethasone, Ropivacaine, Knee arthroscopy, Femoral nerve blocks, Peripheral nerve blocks, Adjuvant, Pediatrics

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Group D

Group R

Group M

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 22, 2013
Last Updated
November 19, 2018
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01971645
Brief Title
Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
Official Title
Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury
Keywords
Dexamethasone, Ropivacaine, Knee arthroscopy, Femoral nerve blocks, Peripheral nerve blocks, Adjuvant, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D
Arm Type
Experimental
Arm Description
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).
Arm Title
Group R
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
Primary Outcome Measure Information:
Title
Intra-operative and Post-operative Opioid Consumption
Description
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Time Frame
Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Secondary Outcome Measure Information:
Title
Post-operative Pain Scores
Description
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.
Time Frame
Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Veneziano, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29377866
Citation
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.
Results Reference
derived

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Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

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