The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine

December 7, 2017 updated by: banu otlar can, Uludag University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bupivacaine,levobupivacaine
20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine
Drug: Levobupivacaine
local injection
Other Names:
  • chirocaine
Drug: Bupivacaine
local injection
Other Names:
  • marcaine
Active Comparator: levobupivacaine
20 ml of 0.5% levobupivacaine saline as a placebo
Drug: Levobupivacaine
local injection
Other Names:
  • chirocaine
Drug: placebo
local injection
Other Names:
  • saline
Active Comparator: bupivacaine
20 ml of 0.5% bupivacaine saline as a placebo
Drug: Bupivacaine
local injection
Other Names:
  • marcaine
Drug: placebo
local injection
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Director: hulya bilgin, uludag university anaesthesia and reanimation department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uludagu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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