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

Not Applicable

• Conditions: Brachial Plexus Block
• Interventions: Procedure: paracoracoid infraclavicular block; Procedure: costoclavicular infraclavicular block; Device: Ultrasound; Drug: Ropivacaine

• Registration Number: NCT03279679
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-09
• Last Update Submitted: 2017-09-09
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12
• Study Start: 2017-10
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
costoclavicular group	Ultrasound	patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
paracoracoid group	paracoracoid infraclavicular block	patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
paracoracoid group	Ultrasound	patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
costoclavicular group	costoclavicular infraclavicular block	patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
costoclavicular group	Ropivacaine	patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
paracoracoid group	Ropivacaine	patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below

Primary Outcome Measures

Name	Time	Method
MEV	The 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 Outcome Measures

Name	Time	Method
performance time	from 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 minutes	time needed for the block performance