Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

Study Overview
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Brief Summary
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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
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The main research questions this trial will answer are: In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative pain compared to placebo? In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative opioid consumption compared to placebo? 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 placebo? This clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus ultrasound-guided scalp block with placebo. 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.

Official Title
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Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised, Double-blind, Placebo-controlled Trial

Conditions
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Pain, Postoperative, Anesthesia

Intervention / Treatment
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* Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%
* Procedure: Ultrasound-guided scalp block with placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All American Society of Anesthesia class I to III patients undergoing elective supratentorial craniotomies under general anaesthesia. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel groups
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-guided scalp with ropivacaine 0.375%<br>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%<br>* 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.<br>|
| Placebo Comparator: Ultrasound-guided scalp with placebo<br>Ultrasound-guided scalp block performed for supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auriculotemporal nerve, superficial cervical plexus, greater occipital nerve and third occipital nerve. Normal saline will be used as placebo. | Procedure: Ultrasound-guided scalp block with placebo<br>* 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, normal saline placebo 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.<br>|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp block, Pain, Supratentorial craniotomy, Ultrasound