ED95 doses of commonly used local anaesthetic agents for ultrasound guided brachial plexus blocks - ED95 Regional Anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018466-22-GB

Enrollment

300

Registered

2010-08-17

Start date

2010-09-22

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NHS patients undergoing routine surgery on hand, arm or shoulder.

Interventions

Trade Name: Chirocaine 2.5mg/ml Product Name: Chirocaine 2.5mg/ml Pharmaceutical Form: Solution for injection Trade Name: Xylocaine 1% with Adrenaline

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA 1-3 patients Age > 18 years Patients of both sex Patients undergoing upper limb and shoulder surgery Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: ASA > 3 Age 40 Pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: To find out the doses (of the most commonly used local anaesthetic agents)that have 95% chance of success for ultrasound guided brachial plexus blocks in patients scheduled for upper limb surgery. (Ultrasound guided brachial plexus block refers to injection of the local anaesthetic drug around the nerves supplying sensation to the shoulder and the arm under ultrasound guidance) ;Secondary Objective: None; Primary end point(s): 1.To find out the ED95 dose of 1% or 2% lidocaine with adrenaline (1:200,000) for axillary brachial plexus block. Assessment of effect of block at 10, 20, and 30 minutes to cold and then pin prick at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb.The trial will conclude at 30 minutes after the injection 2.To find out the ED95 dose of 1% lidocaine with adrenaline (1:200,000) or 1% prilocaine for supraclavicular brachial plexus block. Assessment of effect of block at 10, 20, and 30 minutes to cold and then pin prick at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb.The trial will conclude at 30 minutes after the injection. 3.To determine the ED95 dose of 0.25% levobupivacaine for interscalene block. Assessment of effect of block with VAPS checked at 15, 30, 60, 120 minutes after surgery.The trial will conclude at 120 minutes after the arrival of patient in recovery.	—

Measure

Time frame

Main Objective: To find out the doses (of the most commonly used local anaesthetic agents)that have 95% chance of success for ultrasound guided brachial plexus blocks in patients scheduled for upper limb surgery. (Ultrasound guided brachial plexus block refers to injection of the local anaesthetic drug around the nerves supplying sensation to the shoulder and the arm under ultrasound guidance) ;Secondary Objective: None; Primary end point(s): 1.To find out the ED95 dose of 1% or 2% lidocaine with adrenaline (1:200,000) for axillary brachial plexus block. Assessment of effect of block at 10, 20, and 30 minutes to cold and then pin prick at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb.The trial will conclude at 30 minutes after the injection 2.To find out the ED95 dose of 1% lidocaine with adrenaline (1:200,000) or 1% prilocaine for supraclavicular brachial plexus block. Assessment of effect of block at 10, 20, and 30 minutes to cold and then pin prick at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb.The trial will conclude at 30 minutes after the injection. 3.To determine the ED95 dose of 0.25% levobupivacaine for interscalene block. Assessment of effect of block with VAPS checked at 15, 30, 60, 120 minutes after surgery.The trial will conclude at 120 minutes after the arrival of patient in recovery.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026