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

Posterior Fossa Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852382
• Other study ID #: Cerrahpasa Neuro
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2016
• Last updated: August 18, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• Posterior fossa surgery

• Preoperative GlasGow Coma Score: 15/15

Exclusion Criteria:

• Allergy to bupivacaine

• Uncontrolled hypertension

• Coagulopathy

• Cerebrovascular disease

• Earlier craniotomy

Related Conditions & MeSH terms

• Infratentorial Neoplasms
• Pain, Postoperative
• Posterior Fossa Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Verchère 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	morphine consumption	morphine dosage used (mg) will be recorded in this time periods	30. minute, 1.,2.,6.,12.,24. hours