The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Levobupivacaine; Drug: placebo; Drug: Bupivacaine

• Registration Number: NCT02497040
• Lead Sponsor: Uludag University

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Results First Submitted: 2016-05-15
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Results First Posted: 2018-01-05
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levobupivacaine	placebo	20 ml of 0.5% levobupivacaine saline as a placebo
bupivacaine	placebo	20 ml of 0.5% bupivacaine saline as a placebo
bupivacaine,levobupivacaine	Levobupivacaine	20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine
bupivacaine,levobupivacaine	Bupivacaine	20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine
bupivacaine	Bupivacaine	20 ml of 0.5% bupivacaine saline as a placebo
levobupivacaine	Levobupivacaine	20 ml of 0.5% levobupivacaine saline as a placebo

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure	220+-70 minutes