Clinical trial NCT04398589: The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Suprascapular Nerve Block
Axillary Nerve Block
Dexmedetomidine
Arthroscopic Rotator Cuff Repair
Postoperative Pain
Pain Related Cytokine
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University
First posted: 2020-05-21
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: visual analog scale of pain
timeFrame: change from baseline VAS pain score at hour 48
Secondary outcomes:
measure: patient's satisfaction
timeFrame: change from baseline patient's satisfaction score at hour 48
measure: Plasma cortisol level
timeFrame: change from baseline plasma cortisol level at hour 48
measure: Plasma IL-6 level
timeFrame: change from baseline plasma IL-6 level at hour 48
measure: Plasma IL-8 level
timeFrame: change from baseline plasma IL-8 level at hour 48
measure: Plasma IL-1β level
timeFrame: change from baseline plasma IL-1β level at hour 48
measure: Plasma serotonin level
timeFrame: change from baseline plasma serotonin level at hour 48
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
affiliation: Chuncheon Sacred Heart Hospital, Hallym University Medical College
name: Jung-Taek Hwang, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.