Clinical trial NCT02852382: The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery
Official title: The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posterior Fossa Tumors
Keywords: scalp block
local infiltration
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Heart rate response to head pin replacement and skin incision
timeFrame: Intraoperative
measure: Systolic arterial pressure response to head pin replacement and skin incision
timeFrame: Intraoperative
measure: Diastolic arterial pressure response to head pin replacement and skin incision
timeFrame: Intraoperative
measure: mean arterial pressure response to head pin replacement and skin incision
timeFrame: Intraoperative
Secondary outcomes:
measure: postoperative pain
timeFrame: 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)
measure: morphine consumption
timeFrame: 30. minute, 1.,2.,6.,12.,24. hours
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation
name: Yusuf Tunali, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.