Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

Not Applicable

Recruiting

• Conditions: Pain, Postoperative; Anesthesia
• Interventions: Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%

• Registration Number: NCT06127628
• Lead Sponsor: University Malaysia Sarawak

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-03
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided scalp with ropivacaine 0.375%	Ultrasound-guided scalp block with ropivacaine 0.375%	Ultrasound-guided scalp block performed for supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auriculotemporal nerve, superficial cervical plexus, greater occipital nerve and third occipital nerve. The local anaesthetic used will be ropivacaine 0.375%.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.	Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption postoperatively	Measured at 24 and 48 hours after surgery	Overall postoperative morphine-equivalent consumption
Intraoperative blood pressure stability during stimulating points of surgery	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).	Mean arterial pressures in mmHg at skull-pinning, skin incision and craniotomy.
Intraoperative heart rate stability during stimulating points of surgery	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).	Heart rates in beats per minute at skull-pinning, skin incision and craniotomy.

Trial Locations

Locations (1)

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia