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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

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.

Condition or disease Intervention/treatment Phase
Microtia, Congenital Microtia Anesthesia, Local Anesthesia Procedure: Erector Spinae Plane Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: Treatment Arm
ESP Block
Procedure: Erector Spinae Plane Block
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries

No Intervention: Control Arm
Standard of Care



Primary Outcome Measures :
  1. 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) ]
  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729427


Contacts
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Contact: Ahtziri Fonseca 650-497-0927 aef22011@stanford.edu

Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Contact: Carole Lin, MD         
Principal Investigator: Chi-Ho Ban Tsui, MD         
Sub-Investigator: Carole Lin, MD         
Sponsors and Collaborators
Stanford University
Publications:
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Responsible Party: Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier: NCT03729427    
Other Study ID Numbers: 45160
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Ho Ban Tsui, Stanford University:
Erector Spinae Plane
Erector Spiane Plane Block
Rib Cartilage
Additional relevant MeSH terms:
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Congenital Microtia
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities