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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06127628
Other study ID # NMRR ID-23-03179-N5K
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date October 2025

Study information

Verified date April 2024
Source University Malaysia Sarawak
Contact Samuel Tsan, BMedSc, MD, MAnaes, FCAI
Phone +6082-581000
Email tehsamuel@unimas.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Malaysia Sarawak General Hospital Kuching Sarawak

Sponsors (1)

Lead Sponsor Collaborator
University Malaysia Sarawak

Country where clinical trial is conducted

Malaysia, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Complications of ultrasound-guided scalp block Adverse events Within 48 hours after procedure
Other Postoperative nausea and vomiting Incidence and severity of postoperative nausea and vomiting Within 48 hours after surgery
Other 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
Other Intraoperative anaesthetic usage Amount of intraoperative anaesthetic agents used During surgery
Other Complications associated with opioid usage Complications such as pruritus, respiratory depression, sedation, urinary retention, etc Within 48 hours after surgery
Primary 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 Opioid consumption postoperatively Overall postoperative morphine-equivalent consumption Measured at 24 and 48 hours after surgery
Secondary 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).
Secondary 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).
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