- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398589
The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gangwon-do
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Chuncheon, Gangwon-do, Korea, Republic of, 24253
- Chuncheon Sacred Heart Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SSNB and ANB c DEX
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
|
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.
Other Names:
|
PLACEBO_COMPARATOR: SSNB and ANB c saline
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change from baseline VAS pain score at hour 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient's satisfaction
Time Frame: change from baseline patient's satisfaction score at hour 48
|
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
Time Frame: change from baseline plasma cortisol level at hour 48
|
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
Time Frame: change from baseline plasma IL-6 level at hour 48
|
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
Time Frame: change from baseline plasma IL-8 level at hour 48
|
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
Time Frame: change from baseline plasma IL-1β level at hour 48
|
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
Time Frame: change from baseline plasma serotonin level at hour 48
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jung-Taek Hwang, MD, PhD, Chuncheon Sacred Heart Hospital, Hallym University Medical College
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Ropivacaine
Other Study ID Numbers
- 2015-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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