Phase 4
N=90
The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02497040 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Change in Mean Arterial Pressure — 110; 105; 100 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levobupivacaine (Drug); Bupivacaine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Uludag University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Arterial Pressure |
110; 105; 100 | — |
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).
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.