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

NCT ID: NCT04398589

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-20

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine injection

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Saline injection

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University

OTHER

Sponsor Role collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Taek Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Taek Hwang, MD, PhD

Role: STUDY_CHAIR

Chuncheon Sacred Heart Hospital, Hallym University Medical College

Locations

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Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32975624 (View on PubMed)

Other Identifiers

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2015-20

Identifier Type: -

Identifier Source: org_study_id

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