Suprascapular Nerve BlockPhase 4NCT04398589
The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block
A Phase 4 study testing Dexmedetomidine injection and Saline injection in people with Suprascapular Nerve Block and Axillary Nerve Block, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the duration of regional block. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine
- What is being tested?
- Dexmedetomidine injection and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2015to 30 Jun 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- defined rotator cuff tear on preoperative MRI, which indicated repair
- acceptable arthroscopic surgery, including rotator cuff repair
- patients >20 years old
- acceptable routine regional blocks and patient-controlled analgesia (PCA)
Who cannot join
- did not undergo arthroscopic rotator cuff repair
- stopped PCA before 48 h postoperatively due to side effects
- had a concomitant operation for a Bankart lesion
- had a history of shoulder operation or fracture
- had a concomitant neurological disorder around the shoulder
- underwent conversion to open surgery from the arthroscopy
- had contraindications for the routine regional blocks used in this study
- had an known allergy or hypersensitivity against ropivacaine or dexmedetomidine, including other amino-amide local anesthetics or α2-adrenoceptor agonists.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block on Plasma Cortisol and Pain-related Cytokines After Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the duration of regional block. The aim of this study was to compare the results of dexmedetomidine combined with SSNB and ANB with SSNB and ANB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 hours after arthroscopic rotator cuff repair.
Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single center, double-blinded randomized controlled trial study. Twenty patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using each mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other 20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h postoperatively. The plasma interleukin (IL)-6, -8,-1β, cortisol, and serotonin levels were also measured within 48 h postoperatively.
- Conditions
- Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine, Arthroscopic Rotator Cuff Repair, Postoperative Pain, Pain Related Cytokine
- Being tested
- Dexmedetomidine injection, Saline injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Also called suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.
Saline injectionDrug
Also called suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.
| Study group | Role | What they receive |
|---|---|---|
| SSNB and ANB c DEX | Experimental | We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB. Receives: Drug: Dexmedetomidine injection |
| SSNB and ANB c saline | Placebo comparator | We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB. Receives: Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale of pain
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain.
Measured: change from baseline VAS pain score at hour 48
Secondary outcomes (6)
patient's satisfaction
patient's satisfaction score was based on a scale from 0 to 10, where 0 indicated no satisfaction and 10 indicated much satisfaction.
Measured: change from baseline patient's satisfaction score at hour 48
Plasma cortisol level
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Measured: change from baseline plasma cortisol level at hour 48
Plasma IL-6 level
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Measured: change from baseline plasma IL-6 level at hour 48
Plasma IL-8 level
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Measured: change from baseline plasma IL-8 level at hour 48
Plasma IL-1β level
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Measured: change from baseline plasma IL-1β level at hour 48
Plasma serotonin level
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Measured: change from baseline plasma serotonin level at hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start20 May 2015
- Primary completion18 Dec 2015
- Study completion30 Jun 2016
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 Suprascapular Nerve BlockStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
- Investigators
- Jung-Taek Hwang, MD, PhD, Study chair, Chuncheon Sacred Heart Hospital, Hallym University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398589
- Sponsor's protocol ID
- 2015-20
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will discuss it with our IRB.
Publications
Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
PubMed 32975624
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block on Plasma Cortisol and Pain-related Cytokines After Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04398589
- Acronym / sponsor ID
- 2015-20
- Conditions
- Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine, Arthroscopic Rotator Cuff Repair, Postoperative Pain, Pain Related Cytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University
- Study start
- 20 May 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 21 May 2020 (actual)
- 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.
Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the duration of regional block. The aim of this study was to compare the results of dexmedetomidine combined with SSNB and ANB with SSNB and ANB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 hours after arthroscopic rotator cuff repair.
Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single center, double-blinded randomized controlled trial study. Twenty patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using each mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other 20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h postoperatively. The plasma interleukin (IL)-6, -8,-1β, cortisol, and serotonin levels were also measured within 48 h postoperatively.
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 |
|---|---|---|
| SSNB and ANB c DEX | Experimental | Drug: Dexmedetomidine injectionWe used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB. |
| SSNB and ANB c saline | Placebo comparator | Drug: Saline injectionWe used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- defined rotator cuff tear on preoperative MRI, which indicated repair
- acceptable arthroscopic surgery, including rotator cuff repair
- patients >20 years old
- acceptable routine regional blocks and patient-controlled analgesia (PCA)
Key exclusion criteria (8 listed)
- did not undergo arthroscopic rotator cuff repair
- stopped PCA before 48 h postoperatively due to side effects
- had a concomitant operation for a Bankart lesion
- had a history of shoulder operation or fracture
- had a concomitant neurological disorder around the shoulder
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 |
|---|---|---|
| Dexmedetomidine injectionAlso: suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repairWe used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear. | Drug | SSNB and ANB c DEX |
| Saline injectionAlso: suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repairWe used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear. | Drug | SSNB and ANB c saline |
Primary outcome
visual analog scale of pain
Time frame: change from baseline VAS pain score at hour 48
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain.
6 secondary outcomes
patient's satisfaction
Time frame: change from baseline patient's satisfaction score at hour 48
Plasma cortisol level
Time frame: change from baseline plasma cortisol level at hour 48
Plasma IL-6 level
Time frame: change from baseline plasma IL-6 level at hour 48
Plasma IL-8 level
Time frame: change from baseline plasma IL-8 level at hour 48
Plasma IL-1β level
Time frame: change from baseline plasma IL-1β level at hour 48
Plasma serotonin level
Time frame: change from baseline plasma serotonin level at hour 48
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 21 May 2020.
- Derived from this study: PubMed 32975624Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
- Individual participant dataSharing planned: Yes. We will discuss it with our IRB.
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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.
Jung-Taek Hwang, MD, PhD study chair
Chuncheon Sacred Heart Hospital, Hallym University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine injection and Saline injection in people with Suprascapular Nerve Block and Axillary Nerve Block, run by Chuncheon Sacred Heart 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 4 inclusion and 8 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 21 May 2020. 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. Some participants in this study may receive a placebo. 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?
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?
visual analog scale of pain (time frame: change from baseline VAS pain score at hour 48). 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 NCT04398589, 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 21 May 2020.