Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

Anesthesia Clinical Trial

Official title:

Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127628
• Other study ID #: NMRR ID-23-03179-N5K
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: University Malaysia Sarawak
• Contact: Samuel Tsan, BMedSc, MD, MAnaes, FCAI
• Phone: +6082-581000
• Email: tehsamuel[@]unimas.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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 alcohol abuse

8. Presence of uncontrolled systemic arterial hypertension, severe cardiovascular disease, 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

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative

Intervention

Procedure:
• Ultrasound-guided scalp block with ropivacaine 0.375%
Scalp block will be performed under USG guidance, using the technique described by Tsan et al. The block needle used will be an echogenic block needle, with a length of 50 mm, and a diameter of 22 G. Trained personnel comprising of the investigators in this study will perform the scalp block. Using ultrasound to identify landmarks, ropivacaine 0.375% will be administered in volumes of 1.5 ml to 3 ml. The nerves targeted will be the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater auricular, lesser occipital, greater occipital and third occipital nerves.

Locations

Country	Name	City	State
Malaysia	Sarawak General Hospital	Kuching	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
University Malaysia Sarawak

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Tsan SEH, Goh CH, Tan PCS. Ultrasound-Guided Scalp Blocks for an Awake Craniotomy: A Case Report. A A Pract. 2022 Sep 20;16(9):e01618. doi: 10.1213/XAA.0000000000001618. eCollection 2022 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications of ultrasound-guided scalp block	Adverse events	Within 48 hours after procedure
Other	Postoperative nausea and vomiting	Incidence and severity of postoperative nausea and vomiting	Within 48 hours after surgery
Other	Patient satisfaction with pain management	Satisfaction of participants postoperatively regarding quality of pain management, as measured with Likert scale, 5 being maximal satisfaction, 1 being least satisfaction.	Within 48 hours after surgery
Other	Intraoperative anaesthetic usage	Amount of intraoperative anaesthetic agents used	During surgery
Other	Complications associated with opioid usage	Complications such as pruritus, respiratory depression, sedation, urinary retention, etc	Within 48 hours after surgery
Primary	Postoperative pain	Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.	Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.
Secondary	Opioid consumption postoperatively	Overall postoperative morphine-equivalent consumption	Measured at 24 and 48 hours after surgery
Secondary	Intraoperative blood pressure stability during stimulating points of surgery	Mean arterial pressures in mmHg at skull-pinning, skin incision and craniotomy.	Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).
Secondary	Intraoperative heart rate stability during stimulating points of surgery	Heart rates in beats per minute at skull-pinning, skin incision and craniotomy.	Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).