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NCT Number: NCT02852382

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

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

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Key information

Conditions

Posterior Fossa Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Infratentorial Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: Marcaine

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.

Other names: MORPHİNE PCA

Primary outcomes

  1. Heart rate response to head pin replacement and skin incision

    Time frame: 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

  2. Systolic arterial pressure response to head pin replacement and skin incision

    Time frame: 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

  3. Diastolic arterial pressure response to head pin replacement and skin incision

    Time frame: 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

  4. mean arterial pressure response to head pin replacement and skin incision

    Time frame: 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 outcomes

  1. postoperative pain

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

    pain scores (visual analogue score=VAS) will be evaluated.

  2. morphine consumption

    Time frame: 30. minute, 1.,2.,6.,12.,24. hours

    morphine dosage used (mg) will be recorded in this time periods

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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