USG Brachial Plexus Block for Upper Extremity Surgery

Not Applicable

Completed

• Conditions: Rupture of Tendon of Wrist and Hand; Injuries to the Wrist, Hand and Fingers (S60-S69); Ganglion Cysts; Fracture at Wrist and/or Hand Level; Carpal Tunnel Syndrome
• Interventions: Drug: Ropivacaine

• Registration Number: NCT01993290
• Lead Sponsor: Jens Borglum Neimann

Brief Summary

Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL), Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of the single-penetration multiple-injection-technique.

Detailed Description

The investigators will compare the BP block efficacy (for surgical anaesthesia) with the USG single-penetration multiple-injection-technique at the SCL, LIC and AX level for upper-extremity surgery (elbow, forearm, wrist, hand). The investigators want to investigate whether the single-penetration multiple-injection-technique would provide for safe surgical anaesthesia with lower volumes of local anaesthetics than has previously been described in a comparative study at the three different levels.

120 patients will prospectively be randomized to an USG BP block administered as a single-penetration multiple-injection-technique at one of three different levels: (1) SCL (2) LIC (3) AX. Ropivacaine 0.75% (20 mL) will be used for all blocks prior to surgery.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Primary Completion: 2014-10
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age above 18 years
• American Society of Anaesthesiology class 1-3
• Patients undergoing upper extremity surgery

Exclusion Criteria

• Inability to cooperate
• Inability to understand and talk danish
• Allergic to ropivacaine
• Infection at site of surgery
• Neurological dysfunction at site of surgery
• Severe coagulopathy
• Drug and alcohol abuse
• Patients, who can not get a nerve block due to technical difficulty
• Pregnancy or nursing
• Body mass index >35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USG Axillaris block	Ropivacaine	20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level
USG Supraclavicular block	Ropivacaine	20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.
Lateral infraclavicular block	Ropivacaine	20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level

Primary Outcome Measures

Name	Time	Method
Blockade performance time (seconds)	Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

Secondary Outcome Measures

Name	Time	Method
Duration of time of block postoperatively (hours)	Patient reported the time off ending sensory and motory block
Onset time of blockade (minutes)	Time from block completion to complete sensory and motor block is accomplished.
Number of needle passes	Number of times the direction of the needle changes while performing the block
Patient reported pain related to needle passes (Scale 0-2)	Pain related to block performance reported by the patient right after block completion	0= no pain; 1. middle; 2. sever pain

Trial Locations

Locations (1)

Department of anaesthesiology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark