Phase 4
Completed N=90
The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine
Source: ClinicalTrials.gov NCT02497040 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Change in Mean Arterial Pressure — 110; 105; 100 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II patients were recruited for a randomised, placebo-controlled, double-blind study and were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B; n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30). Scalp block was performed 5 min before head pinning. The primary outcome of the study was mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain was evaluated using a 10-cm visual analogue scale (VAS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Arterial Pressure |
110; 105; 100 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Physical Status classification system 1-2
Exclusion Criteria
- Uncontrolled hypertension, arrhythmia, diabetes mellitus or coagulopathy, coronary artery disease or a proven or suspected allergy to bupivacaine or levobupivacaine
Data sourced from ClinicalTrials.gov (NCT02497040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.