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

NCT02852382 | Completed Phase 2

• 1 other identifier: Cerrahpasa Neuro
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Posterior Fossa Tumors

Keywords

scalp block; local infiltration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• postoperative pain

  30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)

• morphine consumption

  30. minute, 1.,2.,6.,12.,24. hours

Study Arms (3)

scalp block

ACTIVE COMPARATOR

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; Drug: morphine patient controlled analgesia

local infiltration

ACTIVE COMPARATOR

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; Drug: morphine patient controlled analgesia

control

PLACEBO COMPARATOR

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

Drug: morphine patient controlled analgesia

Interventions

Bupivacaine DRUG

In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.

Also known as: Marcaine

local infiltration; scalp block

morphine patient controlled analgesia DRUG

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.

Also known as: MORPHİNE PCA

control; local infiltration; scalp block

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (6)

• 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.

  PMID: 19262392 RESULT

• 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.

  PMID: 21971206 RESULT

• 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.

  PMID: 11907388 RESULT

• 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.

  PMID: 16890064 RESULT

• 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.

  PMID: 14625709 RESULT

• 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.

  PMID: 1408229 RESULT

MeSH Terms

Conditions

Infratentorial Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yusuf Tunali, Professor

  Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff anesthesiologist

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 2, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08