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

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

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

Study Overview

• Status: Completed
• Conditions: Posterior Fossa Tumors
• Intervention / Treatment: Drug: Bupivacaine; Drug: morphine patient controlled analgesia

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: MORPHİNE PCA

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: local infiltration; scalp block
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pain, Postoperative; Infratentorial Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: Cerrahpasa Neuro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided