PainNCT02014766
Supraclavicular Versus Interscalene Block
A study testing Interscalene block and Supraclavicular block in people with Pain, run by Cheju Halla General Hospital at 1 site in South Korea.
Trial summary
We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Interscalene block and Supraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery
Who cannot join
- pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cheju Halla General Hopsital
Jeju City, Jeju Self-governing Province, 670-744
Chunwoo Yang, MD, 82-10-2670-0520, everycw@daum.net
Chunwoo Yang, MD
About this study
Official title: A Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block After Shoulder Surgery
We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.
Read the detailed description
Interscalene block provides effective postoperative analgesia after shoulder surgery. However, it can be associated with significant risk including the phrenic nerve palsy. Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.
- Conditions
- Pain
- Being tested
- Interscalene block, Supraclavicular block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene blockProcedure or surgery
Ultrasound-guided interscalene block is performed.
Supraclavicular blockProcedure or surgery
Ultrasound-guided supraclavicular block is performed
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block | Active comparator | Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected. Receives: Procedure: Interscalene block |
| Supraclavicular block | Experimental | Supraclavicular block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral supraclavicular fossa visualizing the brachial plexus located lateral to the subclavian artery. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected. Receives: Procedure: Supraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain duration
Measured: at 24h after operation
Secondary outcomes (7)
diaphragmatic movement
Measured: preoperative, after block(at 30 min), after operation
motor block
Measured: after block(at 30 min), after operation, at 24h
paresthesia
Measured: after block(at 30min), after operation, at 24h
complications
Measured: after block (at 30 min), after operation, at 24h
supplemental analgesia
Measured: after operation, at 24h
pain score
Measured: at 24h
patient satisfaction
Measured: at 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheju Halla General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunwoo Yang, MD, Principal investigator, Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014766
- Sponsor's protocol ID
- Inter1
- Other IDs
- 2013-M10
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PubMed 20565394Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.
PubMed 20686013
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block After Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02014766
- Acronym / sponsor ID
- Inter1
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cheju Halla General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Dec 2013 (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.
We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.
Detailed description
Interscalene block provides effective postoperative analgesia after shoulder surgery. However, it can be associated with significant risk including the phrenic nerve palsy. Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Active comparator | Procedure: Interscalene blockInterscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected. |
| Supraclavicular block | Experimental | Procedure: Supraclavicular blockSupraclavicular block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral supraclavicular fossa visualizing the brachial plexus located lateral to the subclavian artery. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.375% ropivacaine is injected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery
Key exclusion criteria (1 listed)
- pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication
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 |
|---|---|---|
| Interscalene blockUltrasound-guided interscalene block is performed. | Procedure or surgery | Interscalene block |
| Supraclavicular blockUltrasound-guided supraclavicular block is performed | Procedure or surgery | Supraclavicular block |
Primary outcome
pain duration
Time frame: at 24h after operation
7 secondary outcomes
diaphragmatic movement
Time frame: preoperative, after block(at 30 min), after operation
motor block
Time frame: after block(at 30 min), after operation, at 24h
paresthesia
Time frame: after block(at 30min), after operation, at 24h
complications
Time frame: after block (at 30 min), after operation, at 24h
supplemental analgesia
Time frame: after operation, at 24h
pain score
Time frame: at 24h
patient satisfaction
Time frame: at 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Background: PubMed 20565394Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Results publication: PubMed 20686013Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4.
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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.
Chunwoo Yang, MD principal investigator
Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene block and Supraclavicular block in people with Pain, run by Cheju Halla General Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 18 Dec 2013. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunwoo Yang, MD (82-10-2670-0520, everycw@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain duration (time frame: at 24h after operation). 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 NCT02014766, which also lists 2 linked publications.
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 18 Dec 2013.