PainNCT02342873
Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery
A study testing NS-guided interscalene block and US-guided interscalene block in people with Pain, run by Cheju Halla General Hospital at 1 site in South Korea.
Trial summary
The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block 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?
- NS-guided interscalene block and US-guided interscalene block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical class I - III patients scheduled to undergo shoulder surgery
Who cannot join
- coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cheju Halla General Hopsital
Jeju City, Jeju Special Governing Province, 670-744
About this study
Official title: A Randomized Comparison of Nerve Stimulator-guided and Ultrasound-guided Interscalene Block for Shoulder Surgery
The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.
Read the detailed description
Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.
Therefore, the investigators tested whether nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.
- Conditions
- Pain
- Being tested
- NS-guided interscalene block, US-guided interscalene block
- Keywords
- ultrasound, nerve stimulator
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-guided interscalene blockProcedure or surgery
Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.
US-guided interscalene blockProcedure or surgery
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 0.75% ropivacaine is injected
| Study group | Role | What they receive |
|---|---|---|
| NS-guided interscalene block | Active comparator | NS-guided interscalene block is performed using 20 ml of 0.75% ropivacaine. Receives: Procedure: NS-guided interscalene block |
| US-guided interscalene block | Experimental | US-guided interscalene block is performed using 20 ml of 0.75% ropivacaine. Receives: Procedure: US-guided interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative analgesia
time from completion of local anesthetic injection until the first request for an analgesic
Measured: at 24h after surgery
Secondary outcomes (10)
onset time (complete block of sensory and motor nerve)
complete block of sensory and motor nerve
Measured: until 30min after completion of local anesthetic
patient discomfort (pain score (0 -10) during the procedure)
pain score (0 -10) during the procedure
Measured: at 30 min after block placement
block performance time (the time between the block needle insertion and needle withdrawal)
the time between the block needle insertion and needle withdrawal.
Measured: at 30 min after block placement
The number of needle redirections
either forward or backward movement of needle at least 1 cm or more
Measured: at 30 min after block placement
paresthesia (presence of paresthesia during the procedure)
presence of paresthesia during the procedure
Measured: at 30 min after block placement
motor block of hand
degree of motor block in the operated hand
Measured: at 30 min after block placement
paresthesia of hand
presence of paresthesia in the operated hand
Measured: at 30 min after block placement
Supplemental analgesia
Measured: at 24h after surgery
Pain score
numerical rating scale (0 - 10)
Measured: at 24h after surgery
Patient satisfaction
Patient satisfaction was evaluated using a two-point score: 1, satisfactory (if necessary, I would have the same anesthetic technique); and 2, unsatisfactory (different anesthetic technique).
Measured: at 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheju Halla General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunwoo Yang, Cheju Halla General Hospital
- Investigators
- Chunwoo Yang, MD, Principal investigator, Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342873
- Sponsor's protocol ID
- inter2
- Status last verified
- Jul 2017
- First submitted
- 11 Dec 2014
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
PubMed 25376973Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.
PubMed 18477070
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Nerve Stimulator-guided and Ultrasound-guided Interscalene Block for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02342873
- Acronym / sponsor ID
- inter2
- Conditions
- Pain
- Keywords
- ultrasound, nerve stimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cheju Halla General HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jan 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.
The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.
Detailed description
Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.
Therefore, the investigators tested whether nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.
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 |
|---|---|---|
| NS-guided interscalene block | Active comparator | Procedure: NS-guided interscalene blockNS-guided interscalene block is performed using 20 ml of 0.75% ropivacaine. |
| US-guided interscalene block | Experimental | Procedure: US-guided interscalene blockUS-guided interscalene block is performed using 20 ml of 0.75% ropivacaine. |
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 class I - III patients scheduled to undergo shoulder surgery
Key exclusion criteria (1 listed)
- coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications
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 |
|---|---|---|
| NS-guided interscalene blockPatients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used. | Procedure or surgery | NS-guided interscalene block |
| US-guided 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 0.75% ropivacaine is injected | Procedure or surgery | US-guided interscalene block |
Primary outcome
duration of postoperative analgesia
Time frame: at 24h after surgery
time from completion of local anesthetic injection until the first request for an analgesic
10 secondary outcomes
onset time (complete block of sensory and motor nerve)
Time frame: until 30min after completion of local anesthetic
patient discomfort (pain score (0 -10) during the procedure)
Time frame: at 30 min after block placement
block performance time (the time between the block needle insertion and needle withdrawal)
Time frame: at 30 min after block placement
The number of needle redirections
Time frame: at 30 min after block placement
paresthesia (presence of paresthesia during the procedure)
Time frame: at 30 min after block placement
motor block of hand
Time frame: at 30 min after block placement
paresthesia of hand
Time frame: at 30 min after block placement
Supplemental analgesia
Time frame: at 24h after surgery
Pain score
Time frame: at 24h after surgery
Patient satisfaction
Time frame: at 24h after surgery
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 17 Jul 2017.
- Results publication: PubMed 25376973Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
- Results publication: PubMed 18477070Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.
- Individual participant dataSharing planned: Yes
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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 NS-guided interscalene block and US-guided interscalene 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: finished, as of the sponsor's last update on 17 Jul 2017. 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?
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?
duration of postoperative analgesia (time frame: at 24h after surgery). 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 NCT02342873, 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 17 Jul 2017.