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Completed

NCT Number: NCT02497040

The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

local injection

Other names: chirocaine

Bupivacaine

Drug

local injection

Other names: marcaine

Placebo

Drug

local injection

Other names: saline

Primary outcomes

  1. Change in Mean Arterial Pressure

    Time frame: 220+-70 minutes

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2015
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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