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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.
The main research questions this trial will answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| Standard treatment | No Intervention | Standard perioperative anaesthetic and surgical treatment will be performed, with the omission of ultrasound-guided scalp block |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Tsan, BMedSc, MD, MAnaes, FCAI | Contact | +6082-581000 | 7712 | tehsamuel@unimas.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarawak General Hospital | Recruiting | Kuching | Sarawak | 93586 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36136961 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Parallel groups
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Blinding of participants and outcomes assessor
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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). |
| 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 |
| D012816 | Signs and Symptoms |