Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

NCT06127628 | Recruiting

• 1 other identifier: NMRR ID-23-03179-N5K
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Anesthesia

Keywords

Scalp block; Pain; Supratentorial craniotomy; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Opioid consumption postoperatively

  Measured at 24 and 48 hours after surgery

• 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).

• 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).

Other Outcomes (5)

• Complications of ultrasound-guided scalp block

  Within 48 hours after procedure

• Postoperative nausea and vomiting

  Within 48 hours after surgery

• Patient satisfaction with pain management

  Within 48 hours after surgery

Study Arms (2)

Ultrasound-guided scalp with ropivacaine 0.375%

EXPERIMENTAL

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%.

Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%

Standard treatment

NO INTERVENTION

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

Interventions

Ultrasound-guided scalp block with ropivacaine 0.375% 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.

Ultrasound-guided scalp with ropivacaine 0.375%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Malaysia Sarawak: lead

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Related 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.

  PMID: 36136961 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Samuel Tsan, BMedSc, MD, MAnaes, FCAI

CONTACT

+6082-581000; tehsamuel@unimas.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of participants and outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical lecturer

Model Details: Parallel groups

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)