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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02852382

Enrollment

Registered

2016-08-02

Start date

2014-04-30

Completion date

2016-12-31

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Fossa Tumors

Keywords

scalp block, local infiltration

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.

Interventions

DRUGBupivacaine

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

DRUGmorphine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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
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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026