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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398589
• Other study ID #: 2015-20
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2016
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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 a2-adrenoceptor agonists.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine injection
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.
• Saline injection
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.

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Hallym University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale of pain	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	patient's satisfaction	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
Secondary	Plasma cortisol level	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
Secondary	Plasma IL-6 level	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
Secondary	Plasma IL-8 level	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
Secondary	Plasma IL-1ß level	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-1ß level at hour 48
Secondary	Plasma serotonin level	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