The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine, Arthroscopic Rotator Cuff Repair, Postoperative Pain, Pain Related Cytokine

Intervention / Treatment
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* Drug: Dexmedetomidine injection
* Drug: Saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSNB and ANB c DEX<br>We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB. | Drug: Dexmedetomidine injection<br>* 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.<br>* Other names: arthroscopic rotator cuff repair;|
| Placebo Comparator: SSNB and ANB c saline<br>We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB. | Drug: Saline injection<br>* 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.<br>* Other names: arthroscopic rotator cuff repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline VAS pain score at hour 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | change from baseline plasma serotonin level at hour 48 |