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

Primary Purpose

Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine injection
Saline injection
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suprascapular Nerve Block

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SSNB and ANB c DEX

SSNB and ANB c saline

Arm Description

We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.

We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 8, 2020
Last Updated
May 19, 2020
Sponsor
Chuncheon Sacred Heart Hospital
Collaborators
Hallym University
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1. Study Identification

Unique Protocol Identification Number
NCT04398589
Brief Title
The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2015 (Actual)
Primary Completion Date
December 18, 2015 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital
Collaborators
Hallym University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suprascapular Nerve Block, Axillary Nerve Block, Dexmedetomidine, Arthroscopic Rotator Cuff Repair, Postoperative Pain, Pain Related Cytokine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSNB and ANB c DEX
Arm Type
Experimental
Arm Description
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for SSNB and ANB.
Arm Title
SSNB and ANB c saline
Arm Type
Placebo Comparator
Arm Description
We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for SSNB and ANB.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine injection
Other Intervention Name(s)
suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline injection
Other Intervention Name(s)
suprascapular nerve block and axillary nerve block c ropivacaine, arthroscopic rotator cuff repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual analog scale of pain
Description
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain.
Time Frame
change from baseline VAS pain score at hour 48
Secondary Outcome Measure Information:
Title
patient's satisfaction
Description
patient's satisfaction score was based on a scale from 0 to 10, where 0 indicated no satisfaction and 10 indicated much satisfaction.
Time Frame
change from baseline patient's satisfaction score at hour 48
Title
Plasma cortisol level
Description
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Time Frame
change from baseline plasma cortisol level at hour 48
Title
Plasma IL-6 level
Description
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Time Frame
change from baseline plasma IL-6 level at hour 48
Title
Plasma IL-8 level
Description
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Time Frame
change from baseline plasma IL-8 level at hour 48
Title
Plasma IL-1β level
Description
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Time Frame
change from baseline plasma IL-1β level at hour 48
Title
Plasma serotonin level
Description
A 3-ml blood sample was retrieved from the peripheral vein of the contralateral upper limb or both lower limbs per sampling.
Time Frame
change from baseline plasma serotonin level at hour 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Taek Hwang, MD, PhD
Organizational Affiliation
Chuncheon Sacred Heart Hospital, Hallym University Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
24253
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will discuss it with our IRB.
Citations:
PubMed Identifier
32975624
Citation
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.
Results Reference
derived

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

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