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The Simultaneous Use of Supraclavicular and Distal Blocks

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ClinicalTrials.gov Identifier: NCT01989312
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Basak Ceyda MECO, Ankara University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Orthopaedic Disorders Nerve Block Anaesthesia Procedure: intravenous cannulation. Procedure: Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks. Device: Intravenous cannulation. Device: Routine ASA monitoring Drug: Premedication midazolam Drug: Lidocaine Drug: Epinephrine Drug: Levobupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Active Comparator: 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.
Procedure: intravenous cannulation.
A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site

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

Device: Routine ASA monitoring
Monitorization with ECG, noninvasive blood pressure and spO2.

Drug: Premedication midazolam
Premedication with 0.03 mg/kg midazolam iv

Drug: Lidocaine
Drug: Epinephrine
Active Comparator: 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).
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.

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

Device: Routine ASA monitoring
Monitorization with ECG, noninvasive blood pressure and spO2.

Drug: Premedication midazolam
Premedication with 0.03 mg/kg midazolam iv

Drug: Lidocaine
Drug: Epinephrine
Drug: Levobupivacaine



Primary Outcome Measures :
  1. The time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery. [ Time Frame: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively. ]
    The onset time of supraclavicular plexus block and the onset time of supraclavicular block combined with distal median, radial, and ulnar nerve blocks will be followed up. The time needed to achieve a surgical block will be assessed in both groups. The difference between the 2 groups will be compared and analysed. For this an investigator blinded to the group allocation will evaluate the sensorial pinprick and motor blocks of the ulnar, median, radial and musculocutaneous nerves every 5 minutes starting at the 10th minutes until 30th minutes.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989312


Locations
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Turkey
Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Ankara, Turkey, 06700
Sponsors and Collaborators
Ankara University
Investigators
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Principal Investigator: Basak Ceyda Meco, MD, DESA Ankara University Faculty of Medicine
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Responsible Party: Basak Ceyda MECO, MD,DESA, Ankara University
ClinicalTrials.gov Identifier: NCT01989312    
Other Study ID Numbers: 03-99-12
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Keywords provided by Basak Ceyda MECO, Ankara University:
ultrasound
peripheral nerves
anesthetics
local
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Midazolam
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Adrenergic beta-Agonists
Bronchodilator Agents