AnaesthesiaNCT02805582
Ultrasound Guided Intercostobrachial Nerve Block
A study testing 10ml ropivacain 0.5% in people with Anaesthesia, run by Dr. Christoph Ilies at 1 site in Germany.
Trial summary
The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- 10ml ropivacain 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Feb 2018
- Phase
- Interventional
- 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
- patients planned for vascular access surgery of the upper arm
- surgery planned under regional anaesthesia
Who cannot join
- patients refusal
- age under 18
- allergy against local anaesthetics
- polyneuropathies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Marienhospital Stuttgart, Dpt. of Anaesthesiology
Stuttgart, Baden-Wurttemberg, 70199
About this study
Official title: Area of Sensory Loss, Onset Time and Duration of Two Different Ultrasound Guided Intercostobrachial Nerve Blocks for Vascular Access Surgery of the Upper Arm
The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators compare a proximal and a more distal approach to the nerve referred to onset time, sensory blocked area and duration.
Read the detailed description
The participants will be randomized into two groups:
Group one receives a modified PECS 2 (thoracic wall) block above the second intercostal space with injection between the Musculus serratus anterior and Musculus pectoralis minor.
Group 2 receives a subpectoral block under the pectoralis major muscle at the medial boarder of the axillary triangle.
- Conditions
- Anaesthesia
- Being tested
- 10ml ropivacain 0.5%
- Keywords
- Peripheral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10ml ropivacain 0.5%Drug
Also called ropivacain Sintetica 0.5%
Ultrasound guided nerve block
| Study group | Role | What they receive |
|---|---|---|
| Anterior musculus serratus block | Active comparator | Proximal nerve block above the second intercostal space between Musculus serratus anterior and Musculus pectoralis minor.
Intervention: 10ml ropivacain 0.5% Receives: Drug: 10ml ropivacain 0.5% |
| Subpectoral block | Active comparator | Distal nerve block under the Musculus pectoralis major at the medial border of the axillary triangle.
Intervention: 10ml ropivacain 0.5% Receives: Drug: 10ml ropivacain 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blocked area in squared cm
Area of sensory loss to pin prick test
Measured: Assessment 30 minutes after intervention
Secondary outcomes (3)
Block onset time in minutes
Onset time of complete analgesia. Assessment by pin prick test in the middle of the axilla
Measured: Complete timeframe of 45 minutes with testing every 5 minutes
Block duration in minutes
Complete analgesia to pin prick in the middle of the axilla
Measured: Assessment every 30 minutes for 8 hours after nerve block
The pain numeric rating scale (NRS) during surgical manipulation in the axilla
Measured: From beginning to end of surgery. Estimated mean duration of 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Christoph Ilies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Christoph Ilies, Marienhospital Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805582
- Sponsor's protocol ID
- iCobra 2016
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2016
- Last updated
- 12 Apr 2018
- 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 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Area of Sensory Loss, Onset Time and Duration of Two Different Ultrasound Guided Intercostobrachial Nerve Blocks for Vascular Access Surgery of the Upper Arm
- ClinicalTrials.gov ID
- NCT02805582
- Acronym / sponsor ID
- iCobra 2016
- Conditions
- Anaesthesia
- Keywords
- Peripheral Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. Christoph IliesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Jun 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 intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators compare a proximal and a more distal approach to the nerve referred to onset time, sensory blocked area and duration.
Detailed description
The participants will be randomized into two groups:
Group one receives a modified PECS 2 (thoracic wall) block above the second intercostal space with injection between the Musculus serratus anterior and Musculus pectoralis minor.
Group 2 receives a subpectoral block under the pectoralis major muscle at the medial boarder of the axillary triangle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior musculus serratus block | Active comparator | Drug: 10ml ropivacain 0.5%Proximal nerve block above the second intercostal space between Musculus serratus anterior and Musculus pectoralis minor. Intervention: 10ml ropivacain 0.5% |
| Subpectoral block | Active comparator | Drug: 10ml ropivacain 0.5%Distal nerve block under the Musculus pectoralis major at the medial border of the axillary triangle. Intervention: 10ml ropivacain 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients planned for vascular access surgery of the upper arm
- surgery planned under regional anaesthesia
Key exclusion criteria (4 listed)
- patients refusal
- age under 18
- allergy against local anaesthetics
- polyneuropathies
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 |
|---|---|---|
| 10ml ropivacain 0.5%Also: ropivacain Sintetica 0.5%Ultrasound guided nerve block | Drug | Anterior musculus serratus block, Subpectoral block |
Primary outcome
Blocked area in squared cm
Time frame: Assessment 30 minutes after intervention
Area of sensory loss to pin prick test
3 secondary outcomes
Block onset time in minutes
Time frame: Complete timeframe of 45 minutes with testing every 5 minutes
Block duration in minutes
Time frame: Assessment every 30 minutes for 8 hours after nerve block
The pain numeric rating scale (NRS) during surgical manipulation in the axilla
Time frame: From beginning to end of surgery. Estimated mean duration of 90 minutes.
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 12 Apr 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10ml ropivacain 0.5% in people with Anaesthesia, run by Dr. Christoph Ilies at 1 site in Germany.
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 2 inclusion and 4 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 12 Apr 2018. 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 Germany. 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.
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?
Blocked area in squared cm (time frame: Assessment 30 minutes after intervention). 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 12 Apr 2018.