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

C

Chuncheon Sacred Heart Hospital

Status and phase

Completed
Phase 4

Conditions

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

Treatments

Drug: Saline injection
Drug: Dexmedetomidine injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04398589
2015-20

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

46 participants in 2 patient groups, including a placebo group

SSNB and ANB c DEX
Experimental group
Description:
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
Treatment:
Drug: Dexmedetomidine injection
SSNB and ANB c saline
Placebo Comparator group
Description:
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.
Treatment:
Drug: Saline injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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