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OpenTrials
Completed

NCT Number: NCT02657291

Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study

Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

About this study

Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. A recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. Those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular block in the costoclavicular approach (Group 2). All groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study patients for each group for a total of 70 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory elective surgery of the upper limb
  • ASA (American Society of Anesthesiologists physical status classification system) 1-4
  • Suitable for procedure to be carried out under infraclavicular block

Exclusion criteria

  • Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
  • Ongoing major medical or psychiatric problems
  • Narcotic abuse
  • Peripheral neuropathy or major neurological problems
  • Scarring in area of blockade
  • Inability to co-operate with post-operative evaluation
  • Major coagulopathy
  • Pregnancy and breast-feeding
  • Women of childbearing age who are not taking adequate contraceptive precautions

Treatment and study plan

Ropivacaine

Drug

Local anesthetic

Other names: Naropin

Ultrasound

Device

Ultrasound guided block

Primary outcomes

  1. Block onset time

    Time frame: 1 hour

    From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery

Secondary outcomes

  1. Procedure duration

    Time frame: 1 hour

    From the time the US probe touches the skin to the time the needle is removed

  2. Quality of block

    Time frame: 1 hour

  3. Patient satisfaction

    Time frame: 1 day

    Satisfaction score (VAS ranging from 0 = completely dissatisfied to 10 = completely satisfied)

  4. Requirement for supplemental analgesia or anesthesia

    Time frame: 1 day

    Quality of block will be assessed if adequate for surgery

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Acronym: CPI

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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