Clinical trial NCT06127628: Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy
Official title: Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Anesthesia
Keywords: Scalp block
Pain
Supratentorial craniotomy
Ultrasound
Lead sponsor: University Malaysia Sarawak
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative pain
timeFrame: Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.
Secondary outcomes:
measure: Opioid consumption postoperatively
timeFrame: Measured at 24 and 48 hours after surgery
measure: Intraoperative blood pressure stability during stimulating points of surgery
timeFrame: 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).
measure: Intraoperative heart rate stability during stimulating points of surgery
timeFrame: 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:
measure: Complications of ultrasound-guided scalp block
timeFrame: Within 48 hours after procedure
measure: Postoperative nausea and vomiting
timeFrame: Within 48 hours after surgery
measure: Patient satisfaction with pain management
timeFrame: Within 48 hours after surgery
measure: Intraoperative anaesthetic usage
timeFrame: During surgery
measure: Complications associated with opioid usage
timeFrame: Within 48 hours after surgery
Locations:
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
Study officials:
References:
citation: 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.