Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

Last updated: April 3, 2024
Sponsor: University Malaysia Sarawak
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Treatment

Ultrasound-guided scalp block with ropivacaine 0.375%

Ultrasound-guided scalp block with placebo

Clinical Study ID

NCT06127628
NMRR ID-23-03179-N5K
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Pain management in patients undergoing neurosurgery is a very important issue. The effectiveness of USG-guided scalp blocks for pain management in craniotomy surgery is currently not known. The purpose of this clinical trial is to evaluate the effectiveness of ultrasound-guided scalp block when performed in patients who undergo supratentorial craniotomies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All American Society of Anesthesia class I to III patients undergoing electivesupratentorial craniotomies under general anaesthesia.

Exclusion

Exclusion Criteria:

  1. Refusal to participate in the study
  2. Contraindications to the performance of scalp block, such as local infections
  3. Allergy to ropivacaine hydrochloride
  4. Age < 18 years old
  5. Undergoing emergency craniotomies, posterior fossa surgery, or burr holes surgery
  6. Pre-existing chronic pain (defined as persistent or recurrent pain lasting > 3 months)
  7. History of drug addiction (illicit substances and opioids use) or chronic alcoholabuse
  8. Presence of uncontrolled systemic arterial hypertension, severe cardiovasculardisease, severe kidney or severe liver diseases
  9. Predicted to require postoperative ventilation in the intensive care unit
  10. Psychiatric disorders, serious neurological diseases, or reduced consciousness GCS < 14

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Ultrasound-guided scalp block with ropivacaine 0.375%
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
October 31, 2025

Study Description

The main research questions this trial will answer are:

  1. In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative pain compared to standard treatment?

  2. In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative opioid consumption compared to standard treatment?

  3. In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect intraoperative haemodynamic parameters (blood pressure and heart rate) compared to standard treatment?

This clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus standard treatment.

The findings of this clinical trial may potentially revolutionise the practice of regional anaesthesia and analgesia in intracranial surgeries. This will lead to better patient outcomes by improving the perioperative care of patients undergoing craniotomy surgery.

Connect with a study center

  • Sarawak General Hospital

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

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