The Simultaneous Use of Supraclavicular and Distal Blocks

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989312
• Other study ID #: 03-99-12
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: November 20, 2013
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia
• Nerve Block
• Orthopaedic Disorders

Intervention

Procedure:
• intravenous cannulation.
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.
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
• Routine ASA monitoring
Monitorization with ECG, noninvasive blood pressure and spO2.

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

• Epinephrine

• Levobupivacaine

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	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.