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Completed

NCT Number: NCT01989312

The Simultaneous Use of Supraclavicular and Distal Blocks

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.

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Key information

Conditions

Orthopaedic Disorders Anaesthesia Nerve Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Ankara, 06700, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

intravenous cannulation.

Procedure

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

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

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.

Device

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

Routine ASA monitoring

Device

Monitorization with ECG, noninvasive blood pressure and spO2.

Premedication midazolam

Drug

Premedication with 0.03 mg/kg midazolam iv

Lidocaine

Drug

Epinephrine

Drug

Levobupivacaine

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Nov 21, 2013

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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