OverweightPhase 4NCT02086643
The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Obese Patients
A Phase 4 study testing Retroclavicular block in people with Overweight, run by Université de Sherbrooke at 1 site in Canada.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight
- What is being tested?
- Retroclavicular block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Patients With BMI ≥ 30 kg/m2 : A Descriptive Study
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)
Read the 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.
- Conditions
- Overweight
- Being tested
- Retroclavicular block
- Keywords
- Infraclavicular block, Brachial Plexus, Retroclavicular Approach, Complications of retroclavicular approach, Success of retroclavicular approach, Obese Patients, Obesity and Anesthesia
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroclavicular blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Retroclavicular block | Experimental | Retroclavicular block Receives: Procedure: Retroclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
Secondary outcomes (12)
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).
Measured: Assessed 10, 20 and 30 minutes after block completion
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
Measured: Assessed 10, 20, 30 minutes after the block
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)
Measured: Time required in seconds for the retroclavicular block technique completion, generally under 15 minutes
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.
Measured: 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
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.
Measured: Assessed 1 minute after block completion
Patient satisfaction
Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period.
Measured: Assessed 48 hours after the block
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.
Measured: Assessed 48 hours after the block
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".)
Measured: Assessed 48 hours after the block
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").
Measured: Assessed while surgery in under process
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.
Measured: Assessed during the block
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.
Measured: Assessed during the performance of the nerve block
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.
Measured: Assessed during block performance, throughout surgery and in the PACU. Generally during a period of 4-6 hours after block completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Echave, Université de Sherbrooke
- Investigators
- Pablo Echave, M.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086643
- Sponsor's protocol ID
- 13-175
- Status last verified
- Oct 2015
- First submitted
- 8 Mar 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Retroclavicular Approach for Regional Anesthesia of the Upper Limb in Patients With BMI ≥ 30 kg/m2 : A Descriptive Study
- ClinicalTrials.gov ID
- NCT02086643
- Acronym / sponsor ID
- 13-175
- Conditions
- Overweight
- Keywords
- Infraclavicular block, Brachial Plexus, Retroclavicular Approach, Complications of retroclavicular approach, Success of retroclavicular approach, Obese Patients, Obesity and Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retroclavicular block | Experimental | Procedure: Retroclavicular blockRetroclavicular block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retroclavicular blockRetroclavicular 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. | Procedure or surgery | Retroclavicular block |
Primary outcome
Surgery completion under regional block
Time frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
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.
12 secondary outcomes
Sensitive block progression
Time frame: Assessed 10, 20 and 30 minutes after block completion
Motor Block Progression
Time frame: Assessed 10, 20, 30 minutes after the block
Technique duration
Time frame: Time required in seconds for the retroclavicular block technique completion, generally under 15 minutes
Needle visualization
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
Patient discomfort
Time frame: Assessed 1 minute after block completion
Patient satisfaction
Time frame: Assessed 48 hours after the block
Late Complication Rate
Time frame: Assessed 48 hours after the block
Duration of the Block's Effects
Time frame: Assessed 48 hours after the block
Use of narcotic for tourniquet pain
Time frame: Assessed while surgery in under process
Rate of Neurostimulation Usage
Time frame: Assessed during the block
Failure because of poor ultrasound visualization
Time frame: Assessed during the performance of the nerve block
Early Complication Rate
Time frame: Assessed during block performance, throughout surgery and in the PACU. Generally during a period of 4-6 hours after block completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Echave, M.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retroclavicular block in people with Overweight, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery completion under regional block (time frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.