Forearm InjuriesPhase 4NCT02990702
Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients
A Phase 4 study testing Ultrasound guided retroclavicular block, Ultrasound guided coracoid infraclavicular block and Bupivacaine in people with Forearm Injuries and Hand Injuries, run by Kahramanmaras Sutcu Imam University.
Trial summary
The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forearm Injuries, Hand Injuries
- What is being tested?
- Ultrasound guided retroclavicular block, Ultrasound guided coracoid infraclavicular block and Bupivacaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2017
- 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
- 18-80 years
- BMI>30
- Forearm- Hand surgery
Who cannot join
- <18 years
- Local infection
- Coagulopaty
About this study
Official title: Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese
The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.
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.
- Conditions
- Forearm Injuries, Hand Injuries
- Being tested
- Ultrasound guided retroclavicular block, Ultrasound guided coracoid infraclavicular block, Bupivacaine, Ultrasound
- Keywords
- Infraclavicular block, Retroclavicular block, Ultrasound
- Medical subject headings
- Forearm Injuries, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided retroclavicular blockOther
Also called Group R
Ultrasound guided retroclavicular block for forearm or hand surgery
Ultrasound guided coracoid infraclavicular blockOther
Also called Group C
Ultrasound guided infraclavicular block for forearm or hand surgery
BupivacaineDrug
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided retroclavicular block | Active comparator | Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine Receives: Other: Ultrasound guided retroclavicular block; Other: Ultrasound guided coracoid infraclavicular block; Drug: Bupivacaine; Device: Ultrasound |
| Ultrasound guided infraclavicular block | Active comparator | Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine Receives: Other: Ultrasound guided retroclavicular block; Other: Ultrasound guided coracoid infraclavicular block; Drug: Bupivacaine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technique duration
The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.
Measured: Measured directly during the procedure with a chronometer.
Surgery completion under regional block
Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for 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 (3)
Sensorial 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. 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. 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 completion
Needle visualization
Procedures will be recorded and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good)
Measured: Assessed one week after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm InjuriesStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Bilal, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990702
- Sponsor's protocol ID
- 31
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese
- ClinicalTrials.gov ID
- NCT02990702
- Acronym / sponsor ID
- 31
- Conditions
- Forearm Injuries, Hand Injuries
- Keywords
- Infraclavicular block, Retroclavicular block, Ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 Dec 2016 (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 retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided retroclavicular block | Active comparator | Other: Ultrasound guided retroclavicular block, Other: Ultrasound guided coracoid infraclavicular block, Drug: Bupivacaine, Device: UltrasoundUltrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine |
| Ultrasound guided infraclavicular block | Active comparator | Other: Ultrasound guided retroclavicular block, Other: Ultrasound guided coracoid infraclavicular block, Drug: Bupivacaine, Device: UltrasoundUltrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years
- BMI>30
- Forearm- Hand surgery
Key exclusion criteria (3 listed)
- <18 years
- Local infection
- Coagulopaty
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 |
|---|---|---|
| Ultrasound guided retroclavicular blockAlso: Group RUltrasound guided retroclavicular block for forearm or hand surgery | Other | Ultrasound guided infraclavicular block, Ultrasound guided retroclavicular block |
| Ultrasound guided coracoid infraclavicular blockAlso: Group CUltrasound guided infraclavicular block for forearm or hand surgery | Other | Ultrasound guided infraclavicular block, Ultrasound guided retroclavicular block |
| Bupivacaine | Drug | Ultrasound guided infraclavicular block, Ultrasound guided retroclavicular block |
| Ultrasound | Device | Ultrasound guided infraclavicular block, Ultrasound guided retroclavicular block |
Primary outcome
Technique duration
Time frame: Measured directly during the procedure with a chronometer.
The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.
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 anaesthesia with retroclavicular block without the need for a rescue technique.
3 secondary outcomes
Sensorial 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 completion
Needle visualization
Time frame: Assessed one week after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound guided retroclavicular block, Ultrasound guided coracoid infraclavicular block and Bupivacaine in people with Forearm Injuries and Hand Injuries, run by Kahramanmaras Sutcu Imam University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Technique duration (time frame: Measured directly during the procedure with a chronometer.). The study lists 2 primary outcomes in all. 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 13 Dec 2016.