Craniotomy Surgery, Scalp Nerve Block
Conditions
Keywords
Regional anesthesia, Scalp Nerve Block, Craniotomy, Surgery
Brief summary
The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.
Interventions
PROCEDUREnerve block with 0.5% ropivacaine
Compared to active comparator arm, the experimental arm received the same procedure except in the analgesia maintenance which was performed by nerve block of the scalp using 0.5% ropivacaine. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.
DRUGGeneral anesthesia and opioids (fentanyl, propofol, rocuronium)
Compared to experimental arm, the active comparator arm received the same procedure except in the analgesia maintenance which was performed through continuous fentanyl infusion. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.
Sponsors
Dr. Soetomo Hospital, Surabaya
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Universitas Airlangga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged \>18 years * American Society of Anesthesiologists (ASA) classification I-III * Glasgow Coma Scale (GCS) score ≥ 13 * Elective craniotomy
Exclusion criteria
\- Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | From enrollment until 24 hours post craniotomy surgery. | Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale | 0 to 24 hours after surgery | Pain scale was assessed using the Critical-care Pain Observational Tool (CPOT) every 4 hours |
| Laboratory Markers | After induction of anesthesia, 6 hours after incision, and 24 hours after surgery. | Laboratory markers measured were Interleukin (IL)-6 (pg/mL), Tumor Necrosis Factor (TNF)-α (pg/mL), prostaglandin E2 (PGE2) (pg/mL), cortisol level (μg/dL), blood glucose level (mg/dL), neutrophil count (cells/μL), lymphocyte count (cells/μL) and neutrophil-to-lymphocyte ratio (NLR). |
| The patients with PONV | 0 to 24 hour after surgery | Postoperative nausea and vomiting |
Countries
Indonesia
Outcome results
None listed