Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Anesthesia
• Intervention / Treatment: Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel Tsan, BMedSc, MD, MAnaes, FCAI; Phone Number: 7712 +6082-581000; Email: tehsamuel@unimas.my

Study Locations

• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Recruiting
      • Sarawak General Hospital
      • Contact: Samuel Tsan, BMedSc, MD, MAnaes, FCAI; Phone Number: +6082276666; Email: tehsamuel@unimas.my
      • Principal Investigator: Peter Tan, MD, MMed(Anaesthesiology)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%.	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.
No Intervention: Standard treatment; Standard perioperative anaesthetic and surgical treatment will be performed, with the omission of ultrasound-guided scalp block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption postoperatively	Overall postoperative morphine-equivalent consumption	Measured at 24 and 48 hours after surgery
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of ultrasound-guided scalp block	Adverse events	Within 48 hours after procedure
Postoperative nausea and vomiting	Incidence and severity of postoperative nausea and vomiting	Within 48 hours after surgery
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
Intraoperative anaesthetic usage	Amount of intraoperative anaesthetic agents used	During surgery
Complications associated with opioid usage	Complications such as pruritus, respiratory depression, sedation, urinary retention, etc	Within 48 hours after surgery

Collaborators and Investigators

• Sponsor: University Malaysia Sarawak

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; Scalp block; Supratentorial craniotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: NMRR ID-23-03179-N5K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No