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NCT Number: NCT04398589

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

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.

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Key information

Conditions

Suprascapular Nerve Block Arthroscopic Rotator Cuff Repair Axillary Nerve Block Dexmedetomidine Neurologic Manifestations Pain Pain Related Cytokine Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Injection

Drug

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: suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair

Saline injection

Drug

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: suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Hallym University

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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