Rotator Cuff InjuryNCT02424630
Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block
A study testing Ultrasound-guided ISB, Arthroscopy-guided SSNB and Ropivacaine in people with Rotator Cuff Injury, run by Chuncheon Sacred Heart Hospital.
Trial summary
The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Ultrasound-guided ISB, Arthroscopy-guided SSNB and Ropivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- definite rotator cuff tear on preoperative MRI, which needed repair;
- acceptance of arthroscopic surgery including rotator cuff repair;
- > 20 years old; and
- acceptance of routine regional blocks and patient-controlled analgesia.
Who cannot join
- did not want arthroscopic rotator cuff repair;
- stopped PCA before 48 h postoperatively due to side effects;
- history of shoulder operation or fracture;
- concomitant neurological disorder around the shoulder;
- conversion to open surgery from the arthroscopy; and
- contraindication to the routine regional blocks in this study
About this study
Official title: The Effect of Sono-Guided Interscalene Brachial Plexus Block Combined With Arthroscopy-Guided Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.
Read the detailed description
Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.
- Conditions
- Rotator Cuff Injury
- Being tested
- Ultrasound-guided ISB, Arthroscopy-guided SSNB, Placebo, Ropivacaine
- Keywords
- sono-guided interscalene brachial plexus block, arthroscopy-guided suprascapular nerve block, arthroscopic rotator cuff repair, postoperative pain
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided ISBDevice
ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
Arthroscopy-guided SSNBDevice
At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment.
PlaceboDrug
All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline)
RopivacaineDrug
All the regional blocks in this study were performed using 10mL ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| ISB with SSNB | Experimental | During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine. Receives: Device: Ultrasound-guided ISB; Device: Arthroscopy-guided SSNB; Drug: Placebo; Drug: Ropivacaine |
| ISB alone | Placebo comparator | During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline. Receives: Device: Ultrasound-guided ISB; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
Measured: 1, 3, 6, 12, 18, 24, 36, 48h
Secondary outcomes (1)
Patient Satisfaction (SAT) Score
The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.
Measured: 1, 3, 6, 12, 18, 24, 36, 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 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, Principal investigator, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424630
- Sponsor's protocol ID
- 2013-52
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2015
- Last updated
- 27 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee JJ, Hwang JT, Kim DY, Lee SS, Hwang SM, Lee NR, Kwak BC. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2121-2128. doi: 10.1007/s00167-016-4198-7. Epub 2016 Jun 16.
PubMed 27311449
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sono-Guided Interscalene Brachial Plexus Block Combined With Arthroscopy-Guided Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02424630
- Acronym / sponsor ID
- 2013-52
- Conditions
- Rotator Cuff Injury
- Keywords
- sono-guided interscalene brachial plexus block, arthroscopy-guided suprascapular nerve block, arthroscopic rotator cuff repair, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 27 Aug 2020
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 results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.
Detailed description
Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISB with SSNB | Experimental | Device: Ultrasound-guided ISB, Device: Arthroscopy-guided SSNB, Drug: Placebo, Drug: RopivacaineDuring arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine. |
| ISB alone | Placebo comparator | Device: Ultrasound-guided ISB, Drug: PlaceboDuring arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- definite rotator cuff tear on preoperative MRI, which needed repair;
- acceptance of arthroscopic surgery including rotator cuff repair;
- > 20 years old; and
- acceptance of routine regional blocks and patient-controlled analgesia.
Key exclusion criteria (6 listed)
- did not want arthroscopic rotator cuff repair;
- stopped PCA before 48 h postoperatively due to side effects;
- history of shoulder operation or fracture;
- concomitant neurological disorder around the shoulder;
- conversion to open surgery from the arthroscopy; and
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 |
|---|---|---|
| Ultrasound-guided ISBISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL. | Device | ISB alone, ISB with SSNB |
| Arthroscopy-guided SSNBAt the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment. | Device | ISB with SSNB |
| PlaceboAll the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline) | Drug | ISB alone, ISB with SSNB |
| RopivacaineAll the regional blocks in this study were performed using 10mL ropivacaine. | Drug | ISB with SSNB |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: 1, 3, 6, 12, 18, 24, 36, 48h
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
1 secondary outcome
Patient Satisfaction (SAT) Score
Time frame: 1, 3, 6, 12, 18, 24, 36, 48h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27311449Lee JJ, Hwang JT, Kim DY, Lee SS, Hwang SM, Lee NR, Kwak BC. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2121-2128. doi: 10.1007/s00167-016-4198-7. Epub 2016 Jun 16.
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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 principal investigator
Chuncheon Sacred Heart Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided ISB, Arthroscopy-guided SSNB and Ropivacaine in people with Rotator Cuff Injury, run by Chuncheon Sacred Heart 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 4 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: finished, as of the sponsor's last update on 27 Aug 2020. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (VAS) Pain Score (time frame: 1, 3, 6, 12, 18, 24, 36, 48h). 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 NCT02424630, 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 27 Aug 2020.