The Simultaneous Use of Supraclavicular and Distal Blocks

Phase 4

Completed

• Conditions: Orthopaedic Disorders; Nerve Block; Anaesthesia
• Interventions: 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

• Registration Number: NCT01989312
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-10-31
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supraclavicular block	Routine ASA monitoring	A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
supraclavicular block	Premedication midazolam	A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
Supraclavicular and median, ulnar, radial blocks	Supraclavicular block and ultrasound-guided ulnar, median and radial nerve 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).
Supraclavicular and median, ulnar, radial blocks	Intravenous cannulation.	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).
Supraclavicular and median, ulnar, radial blocks	Routine ASA monitoring	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).
Supraclavicular and median, ulnar, radial blocks	Levobupivacaine	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).
Supraclavicular and median, ulnar, radial blocks	Premedication midazolam	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).
supraclavicular block	Intravenous cannulation.	A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
supraclavicular block	Lidocaine	A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
supraclavicular block	Epinephrine	A supraclavicular block with 32 mL of lidocaine 1.5% + epinephrine 5µg/mL was performed for the anaesthetic management of the forearm and hand.
Supraclavicular and median, ulnar, radial blocks	Lidocaine	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).
Supraclavicular and median, ulnar, radial blocks	Epinephrine	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).

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab; 🇹🇷 Ankara, Turkey