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

Phase 4

Completed

• Conditions: Dexmedetomidine; Postoperative Pain; Arthroscopic Rotator Cuff Repair; Suprascapular Nerve Block; Pain Related Cytokine; Axillary Nerve Block
• Interventions: Drug: Dexmedetomidine injection; Drug: Saline injection

• Registration Number: NCT04398589
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-20
• Primary Completion: 2015-12-18
• Study Completion: 2016-06-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSNB and ANB c DEX	Dexmedetomidine injection	We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
SSNB and ANB c saline	Saline injection	We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.

Primary Outcome Measures

Name	Time	Method
visual analog scale of pain	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.

Secondary Outcome Measures

Name	Time	Method
Plasma cortisol level	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.
patient's satisfaction	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.
Plasma IL-6 level	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.
Plasma serotonin level	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.
Plasma IL-8 level	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.
Plasma IL-1β level	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.

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of