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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01136447
Other study ID # R-06-101
Secondary ID 12208
Status Completed
Phase N/A
First received April 20, 2009
Last updated August 29, 2017
Start date January 2010
Est. completion date February 2013

Study information

Verified date August 2017
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ultrasound guidance or nerve stimulation is the best option for placing continuous peripheral nerve block catheters for upper limb surgery.


Description:

In a multidisciplinary, observer blinded, prospective, single center, randomized study, success rate of US guided versus neurostimulation guided catheter placement for continuous infraclavicular block in patients scheduled for upper limb surgery will be studied. Block effectiveness, time taken, discharge from recovery, postoperative pain and disability and patient acceptance will be studied in 210 patients.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date February 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 18-80 yrs

- Weight 40-100 kg

- Either sex

- Height >150 cm

- American Society of Anesthesiologists physical status 1-3

- Scheduled for hand or elbow surgery under regional anesthesia

Exclusion Criteria:

- Inability to give informed consent

- Refusal of treatment randomization

- Language barrier

- Allergy to any medications being used in the study protocol

- Ongoing major medical or psychiatric problems

- Chronic pain or narcotic use/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

- Patients requiring anesthesia of other surgical sites

- Obese patients (i.e. BMI >40)

- Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual protocol of care

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound
Block catheter will be introduced using ultraosound

Locations

Country Name City State
Canada St. Joseph's Hospital London Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurostimulation versus ultrasound guided infraclavicular catheter placement Comparision of block success with neurostimulation and ultrasound guided placed infraclavicular catheters 14 days
Secondary Time taken for complete nerve block Procedure time for both techniques 14 days
See also
  Status Clinical Trial Phase
Completed NCT03190551 - Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block N/A
Completed NCT02673086 - Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block N/A