Regional AnesthesiaNCT02397330
is There an Alternative to Ultrasound Guided Interscalene Block?
A study testing bupivacaine, ultrasound and morphine in people with Regional Anesthesia and Interscalene Block, run by Tunisian Military Hospital.
Trial summary
Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Regional Anesthesia, Interscalene Block, Shoulder Surgery
- What is being tested?
- bupivacaine, ultrasound and morphine
- 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
- Apr 2015to May 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- 18-75 years of age, inclusive
- shoulder surgery (LATARJET technique)
Who cannot join
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit
- pregnancy
- history of neck surgery or radiotherapy
- severe respiratory disease
- inability to understand the informed consent and demands of the study
About this study
Official title: the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block
Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.
- Conditions
- Regional Anesthesia, Interscalene Block, Shoulder Surgery
- Being tested
- bupivacaine, ultrasound, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
ultrasoundDevice
ultrasound guided nerve blocks
morphineDrug
| Study group | Role | What they receive |
|---|---|---|
| group BIS | Active comparator | scheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25% Receives: Drug: bupivacaine; Device: ultrasound; Drug: morphine |
| group BS | Experimental | scheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks Receives: Drug: bupivacaine; Device: ultrasound; Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale
quality of postoperative analgesia
Measured: until 48 hours postoperative
Secondary outcomes (4)
time to perform the blocks
Measured: up to 5 minutes
patient satisfaction
scale from 0 (not satisfied at all) to 100 (full satisfaction)
Measured: 48 hours post performing nerves blocks
occurrence of complications
Measured: 48 hours post performing nerves blocks
total dose of morphine consumption in mg
Measured: during 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunisian Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr trabelsi walid, Tunisian Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397330
- Sponsor's protocol ID
- TunisianMH1
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Trabelsi W, Ben Gabsia A, Lebbi A, Sammoud W, Labbene I, Ferjani M. Suprascapular block associated with supraclavicular block: An alternative to isolated interscalene block for analgesia in shoulder instability surgery? Orthop Traumatol Surg Res. 2017 Feb;103(1):77-83. doi: 10.1016/j.otsr.2016.10.012. Epub 2016 Dec 2.
PubMed 27916737
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block
- ClinicalTrials.gov ID
- NCT02397330
- Acronym / sponsor ID
- TunisianMH1
- Conditions
- Regional Anesthesia, Interscalene Block, Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tunisian Military HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Mar 2015 (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.
Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group BIS | Active comparator | Drug: bupivacaine, Device: ultrasound, Drug: morphinescheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25% |
| group BS | Experimental | Drug: bupivacaine, Device: ultrasound, Drug: morphinescheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-III
- 18-75 years of age, inclusive
- shoulder surgery (LATARJET technique)
Key exclusion criteria (6 listed)
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit
- pregnancy
- history of neck surgery or radiotherapy
- severe respiratory disease
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 |
|---|---|---|
| bupivacaine | Drug | group BIS, group BS |
| ultrasoundultrasound guided nerve blocks | Device | group BIS, group BS |
| morphine | Drug | group BIS, group BS |
Primary outcome
Visual Analogic Scale
Time frame: until 48 hours postoperative
quality of postoperative analgesia
4 secondary outcomes
time to perform the blocks
Time frame: up to 5 minutes
patient satisfaction
Time frame: 48 hours post performing nerves blocks
occurrence of complications
Time frame: 48 hours post performing nerves blocks
total dose of morphine consumption in mg
Time frame: during 48 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 27916737Trabelsi W, Ben Gabsia A, Lebbi A, Sammoud W, Labbene I, Ferjani M. Suprascapular block associated with supraclavicular block: An alternative to isolated interscalene block for analgesia in shoulder instability surgery? Orthop Traumatol Surg Res. 2017 Feb;103(1):77-83. doi: 10.1016/j.otsr.2016.10.012. Epub 2016 Dec 2.
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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 study testing bupivacaine, ultrasound and morphine in people with Regional Anesthesia and Interscalene Block, run by Tunisian Military Hospital.
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 6 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 24 Mar 2015. 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.
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?
Visual Analogic Scale (time frame: until 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397330, which also lists 1 linked publication.
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 24 Mar 2015.