NCT01993290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

June 10, 2013

Last Update Submit

July 20, 2015

Conditions

Fracture at Wrist and/or Hand LevelRupture of Tendon of Wrist and HandInjuries to the Wrist, Hand and Fingers (S60-S69)Ganglion CystsCarpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Duration of time of block postoperatively (hours)

    Patient reported the time off ending sensory and motory block

Study Arms (3)

USG Supraclavicular block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Lateral infraclavicular block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

USG Axillaris block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

RopivacaineDRUG

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

Also known as: Naropin
Lateral infraclavicular blockUSG Axillaris blockUSG Supraclavicular block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anaesthesiology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 19419356BACKGROUND

  • 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.

    PMID: 21455085BACKGROUND

  • 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.

    PMID: 19920418BACKGROUND

MeSH Terms

Conditions

Ganglion CystsCarpal Tunnel Syndrome

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

CystsNeoplasmsMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mojgan Vazin, MD

    Department of Anaesthesiology, Bispebjerg hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 10, 2013

First Posted

November 25, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

DK(1)