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

NCT04398589 | Completed Phase 4 DMC

• 1 other identifier: 2015-20
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• patient's satisfaction

  change from baseline patient's satisfaction score at hour 48

• Plasma cortisol level

  change from baseline plasma cortisol level at hour 48

• Plasma IL-6 level

  change from baseline plasma IL-6 level at hour 48

• Plasma IL-8 level

  change from baseline plasma IL-8 level at hour 48

• Plasma IL-1β level

  change from baseline plasma IL-1β level at hour 48

Study Arms (2)

SSNB and ANB c DEX

EXPERIMENTAL

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

SSNB and ANB c saline

PLACEBO COMPARATOR

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

Drug: Saline injection

Interventions

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.

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

SSNB and ANB c DEX

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.

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

SSNB and ANB c saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Hallym University: collaborator

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32975624 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jung-Taek Hwang, MD, PhD

  Chuncheon Sacred Heart Hospital, Hallym University Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 21, 2020
• Study Start: May 20, 2015
• Primary Completion: December 18, 2015
• Study Completion: June 30, 2016
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)