The Simultaneous Use of Supraclavicular and Distal Blocks

NCT ID: NCT01989312

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.

Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.

Detailed Description

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Conditions

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Orthopaedic Disorders Nerve Block Anaesthesia

Keywords

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ultrasound peripheral nerves anesthetics local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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supraclavicular block

A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.

Group Type ACTIVE_COMPARATOR

intravenous cannulation.

Intervention Type PROCEDURE

A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

Intravenous cannulation.

Intervention Type DEVICE

A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

Routine ASA monitoring

Intervention Type DEVICE

Monitorization with ECG, noninvasive blood pressure and spO2.

Premedication midazolam

Intervention Type DRUG

Premedication with 0.03 mg/kg midazolam iv

Lidocaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Supraclavicular and median, ulnar, radial blocks

Patients in this group received 20 mL of lidocaine 1.5% + epinephrine 5µg/mL for supraclavicular block and after the supraclavicular block they recieved a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve).

Group Type ACTIVE_COMPARATOR

Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.

Intervention Type PROCEDURE

Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.

Intravenous cannulation.

Intervention Type DEVICE

A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

Routine ASA monitoring

Intervention Type DEVICE

Monitorization with ECG, noninvasive blood pressure and spO2.

Premedication midazolam

Intervention Type DRUG

Premedication with 0.03 mg/kg midazolam iv

Lidocaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Interventions

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intravenous cannulation.

A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

Intervention Type PROCEDURE

Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.

Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.

Intervention Type PROCEDURE

Intravenous cannulation.

A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

Intervention Type DEVICE

Routine ASA monitoring

Monitorization with ECG, noninvasive blood pressure and spO2.

Intervention Type DEVICE

Premedication midazolam

Premedication with 0.03 mg/kg midazolam iv

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 and 80 years old patient
* American Society of Anesthesiologists (ASA) physical status I-III
* Scheduled for elective hand and forearm surgery

Exclusion Criteria

* patient refusal
* preexisting neuropathy
* coagulopathy
* allergy to agents used
* pregnancy
* body mass index \> 35 kg/m2
* chronic obstructive pulmonary disease
* infection or previous surgery in the supraclavicular area
* systemic infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Basak Ceyda MECO

MD,DESA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basak Ceyda Meco, MD, DESA

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine

Locations

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Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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03-99-12

Identifier Type: -

Identifier Source: org_study_id