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Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery

A Randomized Comparison of Minimum Effective Volume With 0.5% Ropivacaine Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03279679
Enrollment
50
Registered
2017-09-12
Start date
2017-10-31
Completion date
2018-07-31
Last updated
2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Block

Keywords

costoclavicular, paracoracoid, brachial plexus

Brief summary

The costoclavicular space block technique is a new developed approach of ultrasound-guided infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied much yet. The paracoracoid approach serves as a standard and traditional method for USG-ICB in clinical practice, easy to learn and perform. The investigators set this parallel controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both two approaches above for forearm surgery and compare the performance time between them, providing reasonable evidence for clinical choice.

Detailed description

The costoclavicular space block technique is a new developed approach of ultrasound-guided infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied much yet. USG-ICB represents an attractive option for upper-limb surgery at or below the elbow joint with similar success rate and fewer adverse effects compared with ultrasound-guided supraclavicular block. The paracoracoid approach serves as a standard and traditional method for USG-ICB in clinical practice, easy to learn and perform. However, the minimum effective volume(MEV)of this approach has been studied by different investigators with different regional anesthetics or its mixture, and specially, the 95% MEV result of this approach is more than 30ml in all related researches which is still a large volume. According to the investigators' experience in using the costoclavicular space technique for forearm surgery, it usually can get a comparable sensation and motor block effect by no more than 25ml. Recently, there was a clinical randomized control study which compared the costoclavicular and paracoracoid USG-ICB for upper limb surgery using a 35ml-mixture of 1% lidocaine-0.25% bupivacaine with epinephrine 5 ug/ml and came to the conclusions: two groups resulted in similar onset times and no intergroup difference were found in terms of performance time and success rate. However, 35ml is a much larger regional anesthetic volume than what we used in routine brachial plexus block. So, we set this parallel controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both approaches above for forearm surgery and compare the performance time between them, providing reasonable evidence for clinical choice. Patients enrolled in this study will be assigned to costoclavicular group and paracoracoid group and in each group, the volume of local anesthetic applied to patients start with 30ml, and then decreased by 2.5ml for next patient when the previous block is successful, otherwise increased by 2.5ml when failed,which is also called a staircase up-and-down method usually applied in dose-finding research of nerve block. After certain reflections of the local anesthetic volume sequential line graph, the minimum effective volume could be calculated.

Interventions

Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine

PROCEDUREparacoracoid infraclavicular block

Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine

DEVICEUltrasound

All the nerve blocks will be performed under realtime ultrasound guidance

DRUGRopivacaine

0.5% ropivacaine will be used for the brachial plexus block in both groups.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

costoclavicular group and paracoracoid group

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* ASA status 1 to 3 * BMI 20-35 * Scheduled for surgery at elbow joint or below

Exclusion criteria

* Inability to consent to the study * Preexisting neuropathy,coagulopathy,COPD * Hepatic or renal failure * Allergy to local anesthetics * Pregnancy * Prior surgery in infraclavicular region

Design outcomes

Primary

MeasureTime frameDescription
MEVThe anesthesia effect of the block with a specified volume fo local anesthetic will be assessed at 30 min after the nerve block finished, the MEV will be calculated after all.minimum effective volume regional anesthetic need for a successful infraclavicular block

Secondary

MeasureTime frameDescription
performance timefrom the time point when ultrasound probe touches with patients' skin to the end when local anesthetic is injected through the needle, which is usually up to ten minutestime needed for the block performance

Contacts

Primary ContactWei Mei, MD
wmei@tjh.tjmu.edu.cn130-0616-2508
Backup ContactShuguang Yang, MD
yangsuperpro@163.com150-7107-8161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026