Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block

NCT ID: NCT03190551

Last Updated: 2017-06-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-04-30

Brief Summary

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The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

Detailed Description

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Infraclavicular blocks are performed with different approaches. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min after local anesthetic injection. Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic are compared with both groups.

Conditions

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Disorder of Upper Extremity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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retroclavicular approach

Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Group Type ACTIVE_COMPARATOR

retroclavicular approach

Intervention Type OTHER

Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

costoclavicular approach

Patients in this group will be randomized to receive an costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Group Type ACTIVE_COMPARATOR

costoclavicular approach

Intervention Type OTHER

costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Interventions

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retroclavicular approach

Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

Intervention Type OTHER

costoclavicular approach

costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hayri Fatih Metinyurt, MD

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Nilgun Kavrut Ozturk, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Ali Sait Kavakli, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AntalyaTRH15

Identifier Type: -

Identifier Source: org_study_id

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