The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Scalp Block With Bupivacaine Versus Levobupivacaine on Haemodynamic Response to Head Pinning and Efficacy on Postoperative Analgesia

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Bupivacaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bupivacaine,levobupivacaine<br>20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine | Drug: Levobupivacaine<br>* local injection<br>* Other names: chirocaine;Drug: Bupivacaine<br>* local injection<br>* Other names: marcaine;|
| Active Comparator: levobupivacaine<br>20 ml of 0.5% levobupivacaine saline as a placebo | Drug: Levobupivacaine<br>* local injection<br>* Other names: chirocaine;Drug: placebo<br>* local injection<br>* Other names: saline;|
| Active Comparator: bupivacaine<br>20 ml of 0.5% bupivacaine saline as a placebo | Drug: Bupivacaine<br>* local injection<br>* Other names: marcaine;Drug: placebo<br>* local injection<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Arterial Pressure |  | 220+-70 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthesia, local anaesthesia, hemodynamics, bupivacaine, levobupivacaine