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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Dexmedetomidine; Suprascapular Nerve Block; Arthroscopic Rotator Cuff Repair; Axillary Nerve Block; Pain Related Cytokine
• Intervention / Treatment: Drug: Dexmedetomidine injection; Drug: Saline injection

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24253
      • Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SSNB and ANB c DEX; We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.	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.; Other Names: suprascapular nerve block and axillary nerve block c ropivacaine; arthroscopic rotator cuff repair
PLACEBO_COMPARATOR: SSNB and ANB c saline; We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.	Drug: 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.; Other Names: suprascapular nerve block and axillary nerve block c ropivacaine; arthroscopic rotator cuff repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Plasma IL-1β 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-1β level at hour 48
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

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Hallym University
• Investigators: Study Chair: Jung-Taek Hwang, MD, PhD, Chuncheon Sacred Heart Hospital, Hallym University Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2015
• Primary Completion (ACTUAL): December 18, 2015
• Study Completion (ACTUAL): June 30, 2016

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: 2015-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will discuss it with our IRB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No