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

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ClinicalTrials.gov Identifier: NCT02852382
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Eren Fatma Akcil, Istanbul University

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

Condition or disease Intervention/treatment Phase
Posterior Fossa Tumors Drug: Bupivacaine Drug: morphine patient controlled analgesia Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arm Intervention/treatment
Active Comparator: scalp block
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.
Drug: Bupivacaine
In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
Other Name: Marcaine

Drug: morphine patient controlled analgesia
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.
Other Name: MORPHİNE PCA

Active Comparator: local infiltration
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.
Drug: Bupivacaine
In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
Other Name: Marcaine

Drug: morphine patient controlled analgesia
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.
Other Name: MORPHİNE PCA

Placebo Comparator: control
In this arm, neither scalp block, nor local infiltration will be performed.
Drug: morphine patient controlled analgesia
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.
Other Name: MORPHİNE PCA




Primary Outcome Measures :
  1. Heart rate response to head pin replacement and skin incision [ Time Frame: Intraoperative ]
    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

  2. Systolic arterial pressure response to head pin replacement and skin incision [ Time Frame: Intraoperative ]
    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

  3. Diastolic arterial pressure response to head pin replacement and skin incision [ Time Frame: Intraoperative ]
    Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

  4. mean arterial pressure response to head pin replacement and skin incision [ Time Frame: Intraoperative ]
    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 :
  1. postoperative pain [ Time Frame: 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS) ]
    pain scores (visual analogue score=VAS) will be evaluated.

  2. morphine consumption [ Time Frame: 30. minute, 1.,2.,6.,12.,24. hours ]
    morphine dosage used (mg) will be recorded in this time periods



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02852382


Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Yusuf Tunali, Professor Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation

Publications of Results:
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Responsible Party: Eren Fatma Akcil, Staff anesthesiologist, Istanbul University
ClinicalTrials.gov Identifier: NCT02852382     History of Changes
Other Study ID Numbers: Cerrahpasa Neuro
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eren Fatma Akcil, Istanbul University:
scalp block
local infiltration
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics