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Brachial Plexus BlockadePhase 4NCT02820688

Concentration-Volume Relationship in Infraclavicular Block

A Phase 4 study testing Bupivacaine 0.25%, Prilocaine 1% and Infraclavicular Nerve Block in people with Brachial Plexus Blockade, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brachial Plexus Blockade
What is being tested?
Bupivacaine 0.25%, Prilocaine 1% and Infraclavicular Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jun 2016to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for upper extremity surgery with infraclavicular nerve block

Who cannot join

  • Patient Refusal
  • Patients younger than 18
  • Patients with known local anesthetic allergies
  • Patients with a BMI>30
  • Diabetic Patients
  • Uncooperated Patients
Show all 11Show fewer
  • Patients with coagulopathy or recieving anticoagulant therapy
  • Skin infection on injection site
  • Patients diagnosed with sepsis or bacteremia
  • Physiologic and emotional lability
  • Surgeries that are expected to last longer than 3 hours

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Bozyaka Training and Research Hospital

    Izmir, İzmir, 35170

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness

This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups

Read the detailed description

Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.

Being tested
Bupivacaine 0.25%, Prilocaine 1%, Infraclavicular Nerve Block, Bupivacaine 0.167%, Bupivacaine 0.125%
Keywords
Local Anesthtetics, Nerve Block, Bupivacaine, Prilocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine 0.25%Drug

    Also called Marcaine

  • Prilocaine 1%Drug

    Also called Citanest

  • Infraclavicular Nerve BlockProcedure or surgery

    Ultrasound guided infraclavicular nerve block

  • Bupivacaine 0.167%Drug

    Also called Marcaine

  • Bupivacaine 0.125%Drug

    Also called Marcaine

  • Prilocaine 0.66%Drug

    Also called Citanest

  • Prilocaine 0.5%Drug

    Also called Citanest

  • UltrasoundDevice

    All nerve blocks will be performed with ultrasound guidance

Study groups in NCT02820688
Study groupRoleWhat they receive
ConcentratedActive comparatorInfraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group
Receives: Drug: Bupivacaine 0.25%; Drug: Prilocaine 1%; Procedure: Infraclavicular Nerve Block; Device: Ultrasound
Diluted by 33%Active comparatorInfraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group
Receives: Procedure: Infraclavicular Nerve Block; Drug: Bupivacaine 0.167%; Drug: Prilocaine 0.66%; Device: Ultrasound
Diluted by 50%Active comparatorInfraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group
Receives: Procedure: Infraclavicular Nerve Block; Drug: Bupivacaine 0.125%; Drug: Prilocaine 0.5%; Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensory Block, as assessed by hollman scale for pinprick test

    Sensorial response to pinprick will be assessed at innervation sites of ulnar median radial and musculocutaneous nerves. Innervation sites of assessment are volar skin of the fifth finger for ulnar nerve, volar skin of second finger for median nerve and dorsal, proximal of the second finger for radial nerve and skin of the anterolateral forearm for musculocutaneous nerve.

    Measured: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute

  2. Motor Block, as assessed by hollman scale for motor blockade

    Motor function for each nerve will be assessed. Movements to be evaluated are; abduction of the fingers for ulnar nerve, thumb opposition for median nerve, extension of the forearm for radial nerve and flexion of the forearm for musculocutaneous nerve.

    Measured: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute

  3. Postoperative Sensory Block, as assessed by hollman scale for pinprick test

    Measured: 1th hour in PACU

  4. Postoperative Motor Block, as assessed by hollman scale for motor blockadet

    Measured: 1th hour in PACU

Secondary outcomes (1)

  1. Pain, as assessed by visual analogue scale

    In addition, patients' first complaint time of pain will be recorded by nurse

    Measured: 1st hour and 6th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820688
Sponsor's protocol ID
ANES-IK-0609
Status last verified
Jan 2017
First submitted
10 Jun 2016
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mosaffa F, Gharaei B, Qoreishi M, Razavi S, Safari F, Fathi M, Mohseni G, Elyasi H, Hosseini F. Do the Concentration and Volume of Local Anesthetics Affect the Onset and Success of Infraclavicular Anesthesia? Anesth Pain Med. 2015 Aug 22;5(4):e23963. doi: 10.5812/aapm.23963v2. eCollection 2015 Aug.

    PubMed 26473102

  • Gonzalez AP, Bernucci F, Techasuk W, Pham K, Finlayson RJ, Tran DQ. A randomized comparison between 3 combinations of volume and concentration of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2013 May-Jun;38(3):206-11. doi: 10.1097/AAP.0b013e318287fe53.

    PubMed 23518863

  • Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0.

    PubMed 26423050

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine 0.25%, Prilocaine 1% and Infraclavicular Nerve Block in people with Brachial Plexus Blockade, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensory Block, as assessed by hollman scale for pinprick test (time frame: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820688, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.

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