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Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients (Scalp block)

Primary Purpose

Tumor, Brain, Anesthesia, Local

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lidocaine
Sodium chloride
Bupivacaine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tumor, Brain

Eligibility Criteria

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

Inclusion Criteria:

->18years of age undergoing elective craniotomy for supratentorial tumors

Exclusion Criteria:

  • Age group < 18
  • Emergency craniotomies
  • Infratentorial tumors.
  • Patients who need intraoperative evoked potential monitoring which precludes the scalp block.
  • Patients with known cranial defects.
  • Patients who are on medications for chronic pain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Scalp block with lidocaine and bupivacaine

    Scalp block with saline

    Arm Description

    Scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.

    Scalp block with saline Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.

    Outcomes

    Primary Outcome Measures

    Overall perioperative comfort of the patient as measured by hemodynamic fluctuations
    Hemodynamic fluctuations during pinning of the head with a Mayfield head-holder and skin incision which represents the most extreme painful stimulation for the entire surgery (significant response being rise in the patient's heart rate and/or the blood pressure more than 20% from the patient's baseline heart rate and/or the blood pressure prior pinning)
    Overall perioperative comfort as measured by opioid requirements
    Overall perioperative opioid requirements until the next morning of the surgery as an overall evaluation of the patient's comfort.

    Secondary Outcome Measures

    Cost-effectiveness of scalp block
    Scalp block for the craniotomy lowers overall administration of opioids, which will decrease the side effects of opioids improve the immediate postoperative pain which may decrease the occurrence of chronic postoperative pain and may result in the early discharge from the hospital contributing to shorter hospital stay reducing the financial burden for both the patient and the hospital.

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    October 20, 2020
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03177252
    Brief Title
    Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients
    Acronym
    Scalp block
    Official Title
    Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator decided not to go forward with the trial.
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Making sure the heart rate and or the blood pressure [called hemodynamic instability] during surgery is stable, setting up for a rapid postoperative recovery, and ensuring that patients have adequate pain relief are some of the important goals of neurosurgical anesthesia. Scalp block anesthesia [injection of a numbing agent into the area of the scalp where the incision will be] together with general anesthesia is used to achieve these goals. There has been some research on whether or not scalp block improves patient recovery and pain management, but the studies have not be large enough to say for certain. This is true even though scalp block is used with almost every patient that is having brain surgery. The investigators propose to determine if scalp block in combination with asleep anesthesia is better than asleep anesthesia alone in patients who are having brain surgery for tumors in the cerebral area of the brain.
    Detailed Description
    Avoidance of hemodynamic fluctuations in the heart rate and or the blood pressure perioperatively, rapid postoperative recovery, and adequate postoperative pain relief are some of the important goals of neurosurgical anesthesia. Scalp block in association with general anesthesia is used to achieve these goals. Previous studies have been published related to the effect of scalp block on the perioperative outcomes on the craniotomy patients. The results reported so far are controversial and one cannot at this point define a positive effect for post-operative pain relief. This disparity in results may be the consequences of the size of the patient population. However scalp block is an accepted practice in the craniotomy patients. The investigators believe this is the first study which assesses the effectiveness of scalp block for asleep craniotomy with the largest sample size study so far conducted in the literature related to this topic. The aim of this study is to assess the effectiveness of scalp block for the perioperative comfort of the craniotomy patients undergoing resection for supratentorial tumors. After the consent for the participation and enrollment in the study is done, patients will be randomized to two groups, a study group will receive a scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine while the control group will receive the scalp block with saline. Intraoperatively, all patients will be preoxygenated, fentanyl (1-2mcg/kg) will be given and anesthesia will be induced with propofol (1-2mg/kg) and lidocaine (1-1.5mg/kg). Tracheal intubation will be facilitated by using either rocuronium (0.6 mg/kg) or succinylcholine (1-1.5mg/kg) intravenously. The lungs will be ventilated with a fresh gas flow of oxygen for 2 minutes before tracheal intubation with cuffed oral endotracheal tube. Anesthesia will be maintained with inhalational anesthetic Isoflurane, Sevoflurane or Desflurane (0.8-1 MAC) and fentanyl infusion (1-2mcg/kg) with the dose adjusted according to the patient's hemodynamics. Bilateral BIS or EEG to maintain an adequate level of depth of anesthesia will be used whenever feasible. After intubation, a scalp block will be performed. The randomization of the scalp block syringes will be provided by the pharmacy and neither the scalp block performer nor the attending will be aware of the syringe content. To standardize the block, a pain specialist is involved. Response to the pinning will be assessed using the hemodynamic parameters and rescue analgesics (fentanyl bolus 50 - 100 mcg) and/or propofol bolus 50 - 100 mg will be given as a bolus if significant response is noted. Significant response being a rise in the patient's heart rate and/or the blood pressure more than 20% from the patient's baseline heart rate and/or the blood pressure just before pinning. Similarly, response to the surgical incision will be noted and rescue analgesics will be given if needed. Intraoperative propofol requirement and opioid requirements will be recorded. The post-operative orders for pain control will be standardized for all the patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tumor, Brain, Anesthesia, Local

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scalp block with lidocaine and bupivacaine
    Arm Type
    Experimental
    Arm Description
    Scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.
    Arm Title
    Scalp block with saline
    Arm Type
    Placebo Comparator
    Arm Description
    Scalp block with saline Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    -2% lidocaine will be given
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium chloride
    Other Intervention Name(s)
    Saline, Normal Saline
    Intervention Description
    -Normal saline will be given
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    -0.5% bupivacaine will be given
    Primary Outcome Measure Information:
    Title
    Overall perioperative comfort of the patient as measured by hemodynamic fluctuations
    Description
    Hemodynamic fluctuations during pinning of the head with a Mayfield head-holder and skin incision which represents the most extreme painful stimulation for the entire surgery (significant response being rise in the patient's heart rate and/or the blood pressure more than 20% from the patient's baseline heart rate and/or the blood pressure prior pinning)
    Time Frame
    Up to 48 hours
    Title
    Overall perioperative comfort as measured by opioid requirements
    Description
    Overall perioperative opioid requirements until the next morning of the surgery as an overall evaluation of the patient's comfort.
    Time Frame
    Up to 48 hours
    Secondary Outcome Measure Information:
    Title
    Cost-effectiveness of scalp block
    Description
    Scalp block for the craniotomy lowers overall administration of opioids, which will decrease the side effects of opioids improve the immediate postoperative pain which may decrease the occurrence of chronic postoperative pain and may result in the early discharge from the hospital contributing to shorter hospital stay reducing the financial burden for both the patient and the hospital.
    Time Frame
    Up to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ->18years of age undergoing elective craniotomy for supratentorial tumors Exclusion Criteria: Age group < 18 Emergency craniotomies Infratentorial tumors. Patients who need intraoperative evoked potential monitoring which precludes the scalp block. Patients with known cranial defects. Patients who are on medications for chronic pain.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umeshkumar Athiraman, M.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

    Learn more about this trial

    Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients

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