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

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ClinicalTrials.gov Identifier: NCT02657291
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Upper Limb Injury Drug: Ropivacaine Device: Ultrasound Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Costoclavicular
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
Drug: Ropivacaine
Local anesthetic
Other Name: Naropin

Device: Ultrasound
Ultrasound guided block

Active Comparator: Paracoracoid
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach
Drug: Ropivacaine
Local anesthetic
Other Name: Naropin

Device: Ultrasound
Ultrasound guided block




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657291


Locations
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Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Shalini Dhir Western University

Publications:
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Responsible Party: Shalini Dhir, Dr., Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02657291     History of Changes
Other Study ID Numbers: LawsonHRI
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Arm Injuries
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents