The Simultaneous Use of Supraclavicular and Distal Blocks

NCT01989312 | Completed Phase 4

• 1 other identifier: 03-99-12
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopaedic Disorders; Nerve Block; Anaesthesia

Keywords

ultrasound; peripheral nerves; anesthetics; local

Outcome Measures

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.

  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.

Study Arms (2)

supraclavicular block

ACTIVE COMPARATOR

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.; Device: Intravenous cannulation.; Device: Routine ASA monitoring; Drug: Premedication midazolam; Drug: Lidocaine; Drug: Epinephrine

Supraclavicular and median, ulnar, radial blocks

ACTIVE COMPARATOR

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.; Device: Intravenous cannulation.; Device: Routine ASA monitoring; Drug: Premedication midazolam; Drug: Lidocaine; Drug: Epinephrine; Drug: Levobupivacaine

Interventions

Intravenous cannulation. PROCEDURE

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

supraclavicular block

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.

Supraclavicular and median, ulnar, radial blocks

Routine ASA monitoring DEVICE

Monitorization with ECG, noninvasive blood pressure and spO2.

Supraclavicular and median, ulnar, radial blocks; supraclavicular block

Premedication midazolam DRUG

Premedication with 0.03 mg/kg midazolam iv

Supraclavicular and median, ulnar, radial blocks; supraclavicular block

Lidocaine DRUG

Supraclavicular and median, ulnar, radial blocks; supraclavicular block

Epinephrine DRUG

Supraclavicular and median, ulnar, radial blocks; supraclavicular block

Levobupivacaine DRUG

Supraclavicular and median, ulnar, radial blocks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab

Ankara, 06700, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine; Levobupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bupivacaine

Study Officials

• Basak Ceyda Meco, MD, DESA

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,DESA

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 21, 2013
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

TU (1)