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Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Primary Purpose

Supratentorial Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scalp Block
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Supratentorial Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>18 years),
  • presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia

Exclusion Criteria:

  • history of allergic reactions on local anesthetics;
  • ASA status ≥ 3;
  • depressed consciousness in pre- or postoperative period;
  • aphasia (as investigators were not able to obtain VAS score).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale score at 24 h after surgery
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),

    Secondary Outcome Measures

    Visual Analogue Scale score at 0
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Visual Analogue Scale score at 2 hours
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Visual Analogue Scale score at 6 hours
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Visual Analogue Scale score at 12 hours
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    time first request of a patient for rescue analgesia
    intraoperative anesthetics
    (and opioids consumption)
    awakening time
    changes in hemodynamics at mayfiled headfraom positioning
    changes in term of blood pressure
    changes in hemodynamics at mayfiled headfraom positioning
    changes in heart rate

    Full Information

    First Posted
    March 30, 2020
    Last Updated
    April 14, 2020
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04344132
    Brief Title
    Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
    Official Title
    Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 20, 2020 (Anticipated)
    Primary Completion Date
    November 30, 2020 (Anticipated)
    Study Completion Date
    December 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Supratentorial Neoplasms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Scalp Block
    Intervention Description
    standard practice of controll the pain after surgery. Block of the nerve emergences.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale score at 24 h after surgery
    Description
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
    Time Frame
    up to 24 hours
    Secondary Outcome Measure Information:
    Title
    Visual Analogue Scale score at 0
    Description
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Time Frame
    Baseline
    Title
    Visual Analogue Scale score at 2 hours
    Description
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Time Frame
    up to 2 hours
    Title
    Visual Analogue Scale score at 6 hours
    Description
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Time Frame
    up to 6 hours
    Title
    Visual Analogue Scale score at 12 hours
    Description
    Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
    Time Frame
    up to 12 hours
    Title
    time first request of a patient for rescue analgesia
    Time Frame
    during surgery
    Title
    intraoperative anesthetics
    Description
    (and opioids consumption)
    Time Frame
    during surgery time
    Title
    awakening time
    Time Frame
    time from the end of surgery to awekening
    Title
    changes in hemodynamics at mayfiled headfraom positioning
    Description
    changes in term of blood pressure
    Time Frame
    surgery
    Title
    changes in hemodynamics at mayfiled headfraom positioning
    Description
    changes in heart rate
    Time Frame
    surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients (>18 years), presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia Exclusion Criteria: history of allergic reactions on local anesthetics; ASA status ≥ 3; depressed consciousness in pre- or postoperative period; aphasia (as investigators were not able to obtain VAS score).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24492515
    Citation
    Bebawy JF, Bilotta F, Koht A. A modified technique for auriculotemporal nerve blockade when performing selective scalp nerve block for craniotomy. J Neurosurg Anesthesiol. 2014 Jul;26(3):271-2. doi: 10.1097/ANA.0000000000000032. No abstract available.
    Results Reference
    background
    PubMed Identifier
    27996204
    Citation
    Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
    Results Reference
    background

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    Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

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