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The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients

Primary Purpose

Overweight

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Retroclavicular block
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Infraclavicular block, Brachial Plexus, Retroclavicular Approach, Complications of retroclavicular approach, Success of retroclavicular approach, Obese Patients, Obesity and Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective or Urgent Surgery of the hand, wrist or forearm
  • 18 years and older
  • Ability to consent
  • American Society of Anesthesiologists class 1 to 3
  • BMI ≥ 30 kg/m2

Exclusion Criteria:

  • Infection at the site of infection
  • Abnormal anatomy at the site of infection
  • Coagulopathy
  • Severe Pulmonary Disease
  • Preexisting neurological symptom(s) in the operated arm
  • Pregnant patients
  • Patients weighing less than 50 kg
  • Allergy to amide type local anesthetics

Sites / Locations

  • Centre hospitalier universitaire de Sherbrooke (CHUS)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retroclavicular block

Arm Description

Retroclavicular block

Outcomes

Primary Outcome Measures

Surgery completion under regional block
Success rate is defined as the completion of the intended surgery under regional anesthesia with retroclavicular block without the need for a rescue technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Patient sedation with midazolam 1 to 2 mg IV or propofol perfusion up to 50 mcg/kg/min is allowed for patient comfort during the surgery and is not considered a rescue technique.

Secondary Outcome Measures

Sensitive block progression
Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion (mepivacaine-ropivacaine mixed injection). The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).
Motor Block Progression
Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion (mepivacaine injection). The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale
Technique duration
Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal (local skin anesthesia plus injection of mepivacaine-ropivacaine mixture)
Needle visualization
Using the Likert standardized scale, two evaluators will individually quantify the ease of needle visualization using the video footage recorded by the ultrasound machine from all the retroclavicular blocks. Likert scale for visualization, is defined as: 1:very bad, 2: bad, 3: adequate, 4:good, 5: very good.
Patient discomfort
Using a Visual Analog Scale (VAS), patients will quantify the discomfort they experienced during the block. This assessment will take place in the minutes following mepivacaine injection and block needle withdrawal. The VAS scale is rated from 1-10, 1 being almost no pain and 10 being the worst pain ever.
Patient satisfaction
Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period.
Late Complication Rate
With a phone call to the patient at 48 hours after injection of mepivacaine-ropivacaine mixture, complications will be searched for (pain at puncture site, paresthesia or paresis in the operated arm, signs of infection at puncture site such as redness or purulent discharge). Response is classified as YES or NO. No units attached to this scale. If patient reports paresthesia or paresis, further questioning over the phone will determine which nerve or cord is involved.
Duration of the Block's Effects
Duration of the block will be evaluated using 3 criteria: patient's subjective opinion of when the block receded (time of the day), time at which first oral analgesia is taken, and time of first onset of pain. Units involved is time (for example "3 pm".)
Use of narcotic for tourniquet pain
If at any point during the surgery, patient complains of tourniquet pain, this will be noted as well as the analgesia given. Units is time of pain ("3 pm") and analgesia given ("micrograms of fentanyl").
Rate of Neurostimulation Usage
At the discretion of the anesthesiologist performing the block, neurostimulation can be used to supplement ultrasound guidance. This will be recorded as a YES or NO (neurostimulation used or not). No units attached to this rate.
Failure because of poor ultrasound visualization
If, for a given patient, during ultrasound guidance the anatomic structure are too poorly visualized to safely perform the block, no puncture will be attempted and the technique will be considered a failure; an alternative anesthesia technique will be proposed to the patient.
Early Complication Rate
Immediate and early complications (vascular puncture, pneumothorax, paresthesia during block performance, pain during infection of the local anesthetics, Horner's syndrome) will be assessed throughout the patient's stay in the OR and PACU. Immediate and appropriate treatment will be provided if necessary.

Full Information

First Posted
March 8, 2014
Last Updated
October 3, 2015
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02086643
Brief Title
The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients
Official Title
The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Patients With BMI ≥ 30 kg/m2 : A Descriptive Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to determine the success rate of the retroclavicular approach for the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)
Detailed Description
Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional. The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy. It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population. Since the retroclavicular variant of the infraclavicular approach for the anesthesia of the brachial plexus offers a better needle visualisation, we believe that this technique can be used successfully in the obese patient population with a low complication rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Infraclavicular block, Brachial Plexus, Retroclavicular Approach, Complications of retroclavicular approach, Success of retroclavicular approach, Obese Patients, Obesity and Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retroclavicular block
Arm Type
Experimental
Arm Description
Retroclavicular block
Intervention Type
Procedure
Intervention Name(s)
Retroclavicular block
Intervention Description
Retroclavicular ultrasound guided nerve block with total injection of 40 ml of a mixture of 20 ml ropivacaine 0,5% (5 mg/ml) + 20 ml mepivacaine 1,5% (15 mg/ml) + epinephrine 1 : 400 000 (2,5 mcg/ml). Incremental injections of 5 ml separated by an aspiration test.
Primary Outcome Measure Information:
Title
Surgery completion under regional block
Description
Success rate is defined as the completion of the intended surgery under regional anesthesia with retroclavicular block without the need for a rescue technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Patient sedation with midazolam 1 to 2 mg IV or propofol perfusion up to 50 mcg/kg/min is allowed for patient comfort during the surgery and is not considered a rescue technique.
Time Frame
Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
Secondary Outcome Measure Information:
Title
Sensitive block progression
Description
Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion (mepivacaine-ropivacaine mixed injection). The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).
Time Frame
Assessed 10, 20 and 30 minutes after block completion
Title
Motor Block Progression
Description
Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion (mepivacaine injection). The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale
Time Frame
Assessed 10, 20, 30 minutes after the block
Title
Technique duration
Description
Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal (local skin anesthesia plus injection of mepivacaine-ropivacaine mixture)
Time Frame
Time required in seconds for the retroclavicular block technique completion, generally under 15 minutes
Title
Needle visualization
Description
Using the Likert standardized scale, two evaluators will individually quantify the ease of needle visualization using the video footage recorded by the ultrasound machine from all the retroclavicular blocks. Likert scale for visualization, is defined as: 1:very bad, 2: bad, 3: adequate, 4:good, 5: very good.
Time Frame
Assessed after study completion, once all 30 patients will have been completed. Assessment will take place in the first 4 weeks after all 30 patients have been recruited
Title
Patient discomfort
Description
Using a Visual Analog Scale (VAS), patients will quantify the discomfort they experienced during the block. This assessment will take place in the minutes following mepivacaine injection and block needle withdrawal. The VAS scale is rated from 1-10, 1 being almost no pain and 10 being the worst pain ever.
Time Frame
Assessed 1 minute after block completion
Title
Patient satisfaction
Description
Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period.
Time Frame
Assessed 48 hours after the block
Title
Late Complication Rate
Description
With a phone call to the patient at 48 hours after injection of mepivacaine-ropivacaine mixture, complications will be searched for (pain at puncture site, paresthesia or paresis in the operated arm, signs of infection at puncture site such as redness or purulent discharge). Response is classified as YES or NO. No units attached to this scale. If patient reports paresthesia or paresis, further questioning over the phone will determine which nerve or cord is involved.
Time Frame
Assessed 48 hours after the block
Title
Duration of the Block's Effects
Description
Duration of the block will be evaluated using 3 criteria: patient's subjective opinion of when the block receded (time of the day), time at which first oral analgesia is taken, and time of first onset of pain. Units involved is time (for example "3 pm".)
Time Frame
Assessed 48 hours after the block
Title
Use of narcotic for tourniquet pain
Description
If at any point during the surgery, patient complains of tourniquet pain, this will be noted as well as the analgesia given. Units is time of pain ("3 pm") and analgesia given ("micrograms of fentanyl").
Time Frame
Assessed while surgery in under process
Title
Rate of Neurostimulation Usage
Description
At the discretion of the anesthesiologist performing the block, neurostimulation can be used to supplement ultrasound guidance. This will be recorded as a YES or NO (neurostimulation used or not). No units attached to this rate.
Time Frame
Assessed during the block
Title
Failure because of poor ultrasound visualization
Description
If, for a given patient, during ultrasound guidance the anatomic structure are too poorly visualized to safely perform the block, no puncture will be attempted and the technique will be considered a failure; an alternative anesthesia technique will be proposed to the patient.
Time Frame
Assessed during the performance of the nerve block
Title
Early Complication Rate
Description
Immediate and early complications (vascular puncture, pneumothorax, paresthesia during block performance, pain during infection of the local anesthetics, Horner's syndrome) will be assessed throughout the patient's stay in the OR and PACU. Immediate and appropriate treatment will be provided if necessary.
Time Frame
Assessed during block performance, throughout surgery and in the PACU. Generally during a period of 4-6 hours after block completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective or Urgent Surgery of the hand, wrist or forearm 18 years and older Ability to consent American Society of Anesthesiologists class 1 to 3 BMI ≥ 30 kg/m2 Exclusion Criteria: Infection at the site of infection Abnormal anatomy at the site of infection Coagulopathy Severe Pulmonary Disease Preexisting neurological symptom(s) in the operated arm Pregnant patients Patients weighing less than 50 kg Allergy to amide type local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Echave, M.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

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The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients

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