Hypertension
Conditions
Keywords
anaesthesia, local anaesthesia, hemodynamics, bupivacaine, levobupivacaine
Brief 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).
Detailed description
Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ University, (the date and protocol number assigned by this ethics committee were March 4, 2008 and 5/30, respectively),written informed consent was obtained from patients undergoing elective scheduled operations involving craniotomy during anaesthesia consultations. Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I or II patients of either sex between 18-85 years of age were allocated to this randomised, prospective, placebo-controlled, double-blind study. The patients were randomly divided into three groups using a sealed-enveloped technique 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)). Twenty-millilitre syringes for the block were prepared and numbered by a blinded assistant.
Interventions
local injection
local injection
local injection
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Arterial Pressure | 220+-70 minutes |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine,Levobupivacaine 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine
Levobupivacaine: local injection
Bupivacaine: local injection | 30 |
| Levobupivacaine 20 ml of 0.5% levobupivacaine saline as a placebo
Levobupivacaine: local injection
placebo: local injection | 30 |
| Bupivacaine 20 ml of 0.5% levobupivacaine saline as a placebo
Bupivacaine: local injection
placebo: local injection | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Bupivacaine,Levobupivacaine | Levobupivacaine | Bupivacaine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 26 Participants | 27 Participants | 78 Participants |
| Region of Enrollment Turkey | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 19 Participants | 53 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 11 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Change in Mean Arterial Pressure
Time frame: 220+-70 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine,Levobupivacaine | Change in Mean Arterial Pressure | 110 mmHg | Standard Deviation 20 |
| Levobupivacaine | Change in Mean Arterial Pressure | 105 mmHg | Standard Deviation 20 |
| Bupivacaine | Change in Mean Arterial Pressure | 100 mmHg | Standard Deviation 20 |