Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

University Malaysia Sarawak

Status: Enrolling

Conditions: Pain, Postoperative; Anesthesia

Treatments: Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%

Study type: Interventional

Funder types: Other

Identifiers

NCT06127628

NMRR ID-23-03179-N5K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ultrasound-guided scalp with ropivacaine 0.375%

Experimental group

Description:

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%.

Treatment:

Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%

Standard treatment

No Intervention group

Description:

Standard perioperative anaesthetic and surgical treatment will be performed, with the omission of ultrasound-guided scalp block