Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy

NCT01971645 | Completed Phase 3 Results DMC

• 1 other identifier: IRB13-00610
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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%.

Conditions

Knee Injury

Keywords

Dexamethasone; Ropivacaine; Knee arthroscopy; Femoral nerve blocks; Peripheral nerve blocks; Adjuvant; Pediatrics

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Post-operative Pain Scores

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

Study Arms (3)

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).

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).

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).

Drug: Dexamethasone; Drug: Ropivacaine

Interventions

Dexamethasone DRUG

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

Group D; Group M

Ropivacaine DRUG

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

Group D; Group M; Group R

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 29377866 DERIVED

MeSH Terms

Conditions

Knee Injuries

Interventions

Dexamethasone; Ropivacaine

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Giorgio Veneziano, MD
• Organization: Nationwide Children's Hospital

Giorgio.Veneziano@nationwidechildrens.org

6147224200

Study Officials

• Giorgio Veneziano, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 29, 2013
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 11, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-11

Locations

US (1)