Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

NCT ID: NCT06127628

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-10-31

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.

Conditions

Pain, Postoperative; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ultrasound-guided scalp 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%.

Group Type: EXPERIMENTAL

Ultrasound-guided scalp block with ropivacaine 0.375%

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Malaysia Sarawak

OTHER

Sponsor Role: lead

Responsible Party

Samuel Ern Hung Tsan

Clinical lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Samuel Tsan, BMedSc, MD, MAnaes, FCAI

Role: CONTACT

tehsamuel@unimas.my

+6082-581000 ext. 7712

Facility Contacts

Samuel Tsan, BMedSc, MD, MAnaes, FCAI

Role: primary

tehsamuel@unimas.my

+6082276666

References

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.

Reference Type: BACKGROUND

PMID: 36136961 (View on PubMed)

Other Identifiers

NMRR ID-23-03179-N5K

Identifier Type: -

Identifier Source: org_study_id