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The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery

Primary Purpose

Posterior Fossa Tumors

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
morphine patient controlled analgesia
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Fossa Tumors focused on measuring scalp block, local infiltration

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Posterior fossa surgery
  • Preoperative GlasGow Coma Score: 15/15

Exclusion Criteria:

  • Allergy to bupivacaine
  • Uncontrolled hypertension
  • Coagulopathy
  • Cerebrovascular disease
  • Earlier craniotomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    scalp block

    local infiltration

    control

    Arm Description

    In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.

    In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.

    In this arm, neither scalp block, nor local infiltration will be performed.

    Outcomes

    Primary Outcome Measures

    Heart rate response to head pin replacement and skin incision
    heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Systolic arterial pressure response to head pin replacement and skin incision
    Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Diastolic arterial pressure response to head pin replacement and skin incision
    Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    mean arterial pressure response to head pin replacement and skin incision
    Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

    Secondary Outcome Measures

    postoperative pain
    pain scores (visual analogue score=VAS) will be evaluated.
    morphine consumption
    morphine dosage used (mg) will be recorded in this time periods

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    August 18, 2017
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02852382
    Brief Title
    The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery
    Official Title
    The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery
    Detailed Description
    In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Fossa Tumors
    Keywords
    scalp block, local infiltration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    scalp block
    Arm Type
    Active Comparator
    Arm Description
    In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.
    Arm Title
    local infiltration
    Arm Type
    Active Comparator
    Arm Description
    In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    In this arm, neither scalp block, nor local infiltration will be performed.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Marcaine
    Intervention Description
    In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
    Intervention Type
    Drug
    Intervention Name(s)
    morphine patient controlled analgesia
    Other Intervention Name(s)
    MORPHİNE PCA
    Intervention Description
    End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
    Primary Outcome Measure Information:
    Title
    Heart rate response to head pin replacement and skin incision
    Description
    heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Time Frame
    Intraoperative
    Title
    Systolic arterial pressure response to head pin replacement and skin incision
    Description
    Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Time Frame
    Intraoperative
    Title
    Diastolic arterial pressure response to head pin replacement and skin incision
    Description
    Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Time Frame
    Intraoperative
    Title
    mean arterial pressure response to head pin replacement and skin incision
    Description
    Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
    Time Frame
    Intraoperative
    Secondary Outcome Measure Information:
    Title
    postoperative pain
    Description
    pain scores (visual analogue score=VAS) will be evaluated.
    Time Frame
    30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)
    Title
    morphine consumption
    Description
    morphine dosage used (mg) will be recorded in this time periods
    Time Frame
    30. minute, 1.,2.,6.,12.,24. hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Posterior fossa surgery Preoperative GlasGow Coma Score: 15/15 Exclusion Criteria: Allergy to bupivacaine Uncontrolled hypertension Coagulopathy Cerebrovascular disease Earlier craniotomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yusuf Tunali, Professor
    Organizational Affiliation
    Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19262392
    Citation
    Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.
    Results Reference
    result
    PubMed Identifier
    21971206
    Citation
    Hansen MS, Brennum J, Moltke FB, Dahl JB. Pain treatment after craniotomy: where is the (procedure-specific) evidence? A qualitative systematic review. Eur J Anaesthesiol. 2011 Dec;28(12):821-9. doi: 10.1097/EJA.0b013e32834a0255.
    Results Reference
    result
    PubMed Identifier
    11907388
    Citation
    Verchere E, Grenier B, Mesli A, Siao D, Sesay M, Maurette P. Postoperative pain management after supratentorial craniotomy. J Neurosurg Anesthesiol. 2002 Apr;14(2):96-101. doi: 10.1097/00008506-200204000-00002.
    Results Reference
    result
    PubMed Identifier
    16890064
    Citation
    Jellish WS, Leonetti JP, Sawicki K, Anderson D, Origitano TC. Morphine/ondansetron PCA for postoperative pain, nausea, and vomiting after skull base surgery. Otolaryngol Head Neck Surg. 2006 Aug;135(2):175-81. doi: 10.1016/j.otohns.2006.02.027.
    Results Reference
    result
    PubMed Identifier
    14625709
    Citation
    Irefin SA, Schubert A, Bloomfield EL, DeBoer GE, Mascha EJ, Ebrahim ZY. The effect of craniotomy location on postoperative pain and nausea. J Anesth. 2003;17(4):227-31. doi: 10.1007/s00540-003-0182-8.
    Results Reference
    result
    PubMed Identifier
    1408229
    Citation
    Schessel DA, Nedzelski JM, Rowed D, Feghali JG. Pain after surgery for acoustic neuroma. Otolaryngol Head Neck Surg. 1992 Sep;107(3):424-9. doi: 10.1177/019459989210700314.
    Results Reference
    result

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    The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery

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