Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy

Sponsor

University Malaysia Sarawak (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06127628

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Anesthesia	Procedure: Ultrasound-guided scalp block with ropivacaine 0.375% Procedure: Ultrasound-guided scalp block with placebo	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel groupsParallel groups

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Blinding of participants and investigators

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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.
Placebo Comparator: Ultrasound-guided scalp with placebo 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 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.

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.

Placebo Comparator: Ultrasound-guided scalp with placebo

Procedure: Ultrasound-guided scalp block with placebo

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.

Outcome Measures

Primary Outcome Measures

Postoperative pain [Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.]
Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.

Secondary Outcome Measures

Opioid consumption postoperatively [Measured at 24 and 48 hours after surgery]
Overall postoperative morphine-equivalent consumption
Intraoperative blood pressure stability during stimulating points of surgery [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).]
Mean arterial pressures in mmHg at skull-pinning, skin incision and craniotomy.
Intraoperative heart rate stability during stimulating points of surgery [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).]
Heart rates in beats per minute at skull-pinning, skin incision and craniotomy.

Other Outcome Measures

Complications of ultrasound-guided scalp block [Within 48 hours after procedure]
Adverse events
Postoperative nausea and vomiting [Within 48 hours after surgery]
Incidence and severity of postoperative nausea and vomiting
Patient satisfaction with pain management [Within 48 hours after surgery]
Satisfaction of participants postoperatively regarding quality of pain management, as measured with Likert scale, 5 being maximal satisfaction, 1 being least satisfaction.
Intraoperative anaesthetic usage [During surgery]
Amount of intraoperative anaesthetic agents used
Complications associated with opioid usage [Within 48 hours after surgery]
Complications such as pruritus, respiratory depression, sedation, urinary retention, etc

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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