USG Brachial Plexus Block for Upper Extremity Surgery

NCT ID: NCT01993290

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Fracture at Wrist and/or Hand Level Rupture of Tendon of Wrist and Hand Injuries to the Wrist, Hand and Fingers (S60-S69) Ganglion Cysts Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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USG Supraclavicular block

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

Lateral infraclavicular block

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

USG Axillaris block

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

Interventions

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Ropivacaine

20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jens Borglum Neimann

OTHER

Sponsor Role lead

Responsible Party

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Jens Borglum Neimann

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mojgan Vazin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Bispebjerg hospital

Locations

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Department of anaesthesiology, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.

Reference Type BACKGROUND
PMID: 19419356 (View on PubMed)

Mariano ER, Sandhu NS, Loland VJ, Bishop ML, Madison SJ, Abrams RA, Meunier MJ, Ferguson EJ, Ilfeld BM. A randomized comparison of infraclavicular and supraclavicular continuous peripheral nerve blocks for postoperative analgesia. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):26-31. doi: 10.1097/AAP.0b013e318203069b.

Reference Type BACKGROUND
PMID: 21455085 (View on PubMed)

Tran DQ, Munoz L, Zaouter C, Russo G, Finlayson RJ. A prospective, randomized comparison between single- and double-injection, ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):420-4. doi: 10.1097/AAP.0b013e3181ae733a.

Reference Type BACKGROUND
PMID: 19920418 (View on PubMed)

Other Identifiers

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H-2-2012-055

Identifier Type: OTHER

Identifier Source: secondary_id

BBH-PB

Identifier Type: -

Identifier Source: org_study_id

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