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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in

Conditions
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Posterior Fossa Tumors

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: morphine patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Posterior fossa surgery Preoperative GlasGow Coma Score: 15/15 Exclusion Criteria: Allergy to bupivacaine Uncontrolled hypertension Coagulopathy Cerebrovascular disease Earlier craniotomy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: scalp block<br>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<br>* In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.<br>* Other names: Marcaine;Drug: morphine patient controlled analgesia<br>* 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.<br>* Other names: MORPHİNE PCA;|
| Active Comparator: local infiltration<br>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<br>* In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.<br>* Other names: Marcaine;Drug: morphine patient controlled analgesia<br>* 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.<br>* Other names: MORPHİNE PCA;|
| Placebo Comparator: control<br>In this arm, neither scalp block, nor local infiltration will be performed. | Drug: morphine patient controlled analgesia<br>* 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.<br>* Other names: MORPHİNE PCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Intraoperative | 
| 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 | Intraoperative | 
| 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 | Intraoperative | 
| 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 | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | pain scores (visual analogue score=VAS) will be evaluated. | 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS) | 
| morphine consumption | morphine dosage used (mg) will be recorded in this time periods | 30. minute, 1.,2.,6.,12.,24. hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scalp block, local infiltration