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Rib Microtia and the Erector Spinae Plane (ESP) Block

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ClinicalTrials.gov Identifier: NCT03729427
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date May 24, 2021
Estimated Study Start Date  ICMJE July 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Opiate Intake in Morphine Equivalents in Both Control and Treatment Group [ Time Frame: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days) ]
  • Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain) [ Time Frame: Duration of Study (Typically 4-5 days) ]
    Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
  • Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale [ Time Frame: Duration of Study (Typically 4-5 days) ]
    Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
  • Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale [ Time Frame: Duration of Study (Typically 4-5 days) ]
    Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rib Microtia and the Erector Spinae Plane (ESP) Block
Official Title  ICMJE Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
Brief Summary The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Microtia, Congenital
  • Microtia
  • Anesthesia, Local
  • Anesthesia
Intervention  ICMJE Procedure: Erector Spinae Plane Block
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries
Study Arms  ICMJE
  • Experimental: Treatment Arm
    ESP Block
    Intervention: Procedure: Erector Spinae Plane Block
  • No Intervention: Control Arm
    Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 2-17
  • Able to consent (if greater than 7 years) and have parental consent
  • Pediatric patients undergoing rib cartilage resection surgeries

Exclusion Criteria:

  • Participants who do not consent or have parental consent
  • Patients who are clinically unstable or requires urgent/emergent intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahtziri Fonseca 650-497-0927 aef22011@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729427
Other Study ID Numbers  ICMJE 45160
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chi-Ho Ban Tsui, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP