Rotator Cuff Injury
Conditions
Keywords
sono-guided interscalene brachial plexus block, arthroscopy-guided suprascapular nerve block, arthroscopic rotator cuff repair, postoperative pain
Brief 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.
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.
Interventions
DEVICEUltrasound-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.
DEVICEArthroscopy-guided SSNB
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.
DRUGPlacebo
All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline)
DRUGRopivacaine
All the regional blocks in this study were performed using 10mL ropivacaine.
Sponsors
Hallym University
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. definite rotator cuff tear on preoperative MRI, which needed repair; 2. acceptance of arthroscopic surgery including rotator cuff repair; 3. \> 20 years old; and 4. acceptance of routine regional blocks and patient-controlled analgesia.
Exclusion criteria
1. did not want arthroscopic rotator cuff repair; 2. stopped PCA before 48 h postoperatively due to side effects; 3. history of shoulder operation or fracture; 4. concomitant neurological disorder around the shoulder; 5. conversion to open surgery from the arthroscopy; and 6. contraindication to the routine regional blocks in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (SAT) Score | 1, 3, 6, 12, 18, 24, 36, 48h | The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory. |
Participant flow
Recruitment details
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.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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 | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No rotator cuff tear | 1 | 2 |
| Overall Study | Open procedure | 0 | 1 |
Baseline characteristics
| Characteristic | ISB With SSNB | ISB Alone | Total |
|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 9.6 | 57.3 years STANDARD_DEVIATION 12 | 57.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
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
Time frame: 1, 3, 6, 12, 18, 24, 36, 48h
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 1h | 2.0 units on a scale | Standard Deviation 1.2 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 3h | 1.7 units on a scale | Standard Deviation 1 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 6h | 1.6 units on a scale | Standard Deviation 1.1 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 12h | 3.5 units on a scale | Standard Deviation 1.9 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 18h | 3.6 units on a scale | Standard Deviation 1.7 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 24h | 3.2 units on a scale | Standard Deviation 1.7 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 36h | 2.1 units on a scale | Standard Deviation 1.1 |
| ISB With SSNB | Visual Analog Scale (VAS) Pain Score | 48h | 1.3 units on a scale | Standard Deviation 0.8 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 48h | 2.0 units on a scale | Standard Deviation 0.7 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 1h | 2.6 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 18h | 5.2 units on a scale | Standard Deviation 1.6 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 3h | 2.6 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 36h | 2.7 units on a scale | Standard Deviation 1 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 6h | 4.0 units on a scale | Standard Deviation 2.2 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 24h | 4.2 units on a scale | Standard Deviation 1.5 |
| ISB Alone | Visual Analog Scale (VAS) Pain Score | 12h | 5.8 units on a scale | Standard Deviation 1.5 |
Secondary
Patient Satisfaction (SAT) Score
The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.
Time frame: 1, 3, 6, 12, 18, 24, 36, 48h
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ISB With SSNB | Patient Satisfaction (SAT) Score | 1h | 7.9 units on a scale | Standard Deviation 1.3 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 18h | 6.4 units on a scale | Standard Deviation 1.3 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 6h | 7.8 units on a scale | Standard Deviation 1 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 24h | 6.9 units on a scale | Standard Deviation 1.2 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 3h | 7.8 units on a scale | Standard Deviation 1.1 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 36h | 7.9 units on a scale | Standard Deviation 1.1 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 48h | 8.5 units on a scale | Standard Deviation 0.6 |
| ISB With SSNB | Patient Satisfaction (SAT) Score | 12h | 6.2 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Patient Satisfaction (SAT) Score | 48h | 8.2 units on a scale | Standard Deviation 0.9 |
| ISB Alone | Patient Satisfaction (SAT) Score | 1h | 7.2 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Patient Satisfaction (SAT) Score | 3h | 7.3 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Patient Satisfaction (SAT) Score | 6h | 6.0 units on a scale | Standard Deviation 1.9 |
| ISB Alone | Patient Satisfaction (SAT) Score | 12h | 4.3 units on a scale | Standard Deviation 1.4 |
| ISB Alone | Patient Satisfaction (SAT) Score | 18h | 5.1 units on a scale | Standard Deviation 1.5 |
| ISB Alone | Patient Satisfaction (SAT) Score | 24h | 5.9 units on a scale | Standard Deviation 1.7 |
| ISB Alone | Patient Satisfaction (SAT) Score | 36h | 7.1 units on a scale | Standard Deviation 1.2 |