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

Phase 2

Completed

• Conditions: Posterior Fossa Tumors
• Interventions: Drug: Bupivacaine; Drug: morphine patient controlled analgesia

• Registration Number: NCT02852382
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local infiltration	morphine patient controlled analgesia	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.
scalp block	morphine patient controlled analgesia	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.
control	morphine patient controlled analgesia	In this arm, neither scalp block, nor local infiltration will be performed.
local infiltration	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.
scalp block	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Systolic arterial pressure response to head pin replacement and skin incision	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
mean arterial pressure response to head pin replacement and skin incision	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
Heart rate response to head pin replacement and skin incision	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
Diastolic arterial pressure response to head pin replacement and skin incision	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

Secondary Outcome Measures

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