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| Name | Class |
|---|---|
| Hallym University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided ISB | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1, 3, 6, 12, 18, 24, 36, 48h |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction (SAT) Score | The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory. | 1, 3, 6, 12, 18, 24, 36, 48h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Taek Hwang, MD, PhD | Chuncheon Sacred Heart Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27311449 | Derived | 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. |
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Assessed for eligibility (n= 54) Excluded (n= 2) previous fracture history of affected shoulder (n= 1) previous cerebral palsy history involving affected shoulder(n= 1) preassignment(n=52)
Rotator cuff tears were diagnosed by preoperative MRI, and the size of the rotator cuff was confirmed at the time of surgery. The indication for surgery was a symptomatic full thickness rotator cuff tear or a > 50% thickness partial thickness rotator cuff tear. From Aug 2013 to Jul 2014, the recruitment was done at Orthopeic department.
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| ID | Title | Description |
|---|---|---|
| FG000 | ISB With SSNB | 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. Ultrasound-guided ISB: 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 SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. |
| FG001 | ISB Alone | 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. Ultrasound-guided ISB: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A power analysis indicated that 44 patients (22 patients in each cohort) would provide a statistical power of 80% with a two-sided α-level of 0.05 to detect a significant difference in the VAS score 12 h postoperatively, assuming an effect size of 0.89 (mean difference, 1.6; standard deviation [SD], 1.8).
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| ID | Title | Description |
|---|---|---|
| BG000 | ISB With SSNB | 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. Ultrasound-guided ISB: 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 SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 1, 3, 6, 12, 18, 24, 36, 48h |
|
During operation
During operation, hypoxia was checked using arterial SaO2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISB With SSNB | 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. Ultrasound-guided ISB: 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 SSNB: At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jung-Taek Hwang | Chuncheon Sacred Heart Hospital | 82 33 240 5197 | drakehjt@hanmail.net |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Arthroscopy-guided SSNB | Device | 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. |
|
| Placebo | Drug | All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline) |
|
| Ropivacaine | Drug | All the regional blocks in this study were performed using 10mL ropivacaine. |
|
| BG001 | ISB Alone | 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. Ultrasound-guided ISB: 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. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Patient Satisfaction (SAT) Score | The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory. | Posted | Mean | Standard Deviation | units on a scale | 1, 3, 6, 12, 18, 24, 36, 48h |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | ISB Alone | 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. Ultrasound-guided ISB: 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. | 0 | 27 | 0 | 27 |
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| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| 6h |
|
| 12h |
|
| 18h |
|
| 24h |
|
| 36h |
|
| 48h |
|