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Clinical Trials/NCT01993290
NCT01993290
Completed
Not Applicable

Ultrasound-guided Brachial Plexus Block With the Single-penetration Multiple-injection-technique for Upper Extremity Surgery

Jens Borglum Neimann1 site in 1 country120 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Fracture at Wrist and/or Hand Level
Sponsor
Jens Borglum Neimann
Enrollment
120
Locations
1
Primary Endpoint
Blockade performance time (seconds)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jens Borglum Neimann
Responsible Party
Sponsor Investigator
Principal Investigator

Jens Borglum Neimann

Associate professor

Bispebjerg Hospital

Eligibility Criteria

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

Arms & Interventions

USG Supraclavicular block

20 ml of ropivacaine 0,75% is administered to brachial plexus at supraclavicular level.

Intervention: Ropivacaine

Lateral infraclavicular block

20 ml of ropivacaine 0,75 % is administered to brachialis plexus at lateral infraclavicular level

Intervention: Ropivacaine

USG Axillaris block

20 ml of ropivacaine 0,75% is administered to plexus brachialis at axillaris level

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Blockade performance time (seconds)

Time Frame: Time (seconds) from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.

Secondary Outcomes

  • 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)

Study Sites (1)

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