Anesthesia, Pain, Postoperative
Conditions
Keywords
Scalp block, Pain, Supratentorial craniotomy, Ultrasound
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.
Interventions
PROCEDUREUltrasound-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.
Sponsors
University Malaysia Sarawak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of participants and outcomes assessor
Intervention model description
Parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complications of ultrasound-guided scalp block | Within 48 hours after procedure | Adverse events |
| Complications associated with opioid usage | Within 48 hours after surgery | Complications such as pruritus, respiratory depression, sedation, urinary retention, etc |
| 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 |
Countries
Malaysia
Contacts
Primary ContactSamuel Tsan, BMedSc, MD, MAnaes, FCAI
Outcome results
None listed