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Axillary Nerve Block Combined With Suprascapular Nerve Block (SSNBANB)

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ClinicalTrials.gov Identifier: NCT02060812
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

Brief Summary:

Purpose: The purpose of this study is to compare the result of combined sono-guided suprascapular nerve block (SSNB) and axillary nerve block (ANB) with isolated SSNB in postoperative pain following arthroscopic rotator cuff repair. Our hypothesis was that SSNB combined ANB would show a more effective anesthesia for arthroscopic rotator cuff repair as compared with SSNB only.

Methods: Forty-two patients with rotator cuff tear who had undergone arthroscopic rotator cuff repair were enrolled in this study. Among them, 21 patients were randomly allocated into group I, and received SSNB and ANB with each 10mL ropivacaine. The other 21 patients were allocated into group II, and received SSNB with 10mL ropivacaine and ANB with 10mL normal saline. Visual Analogue Scale (VAS) pain score, patient's satisfaction (SAT), and Lateral Pain Index (LPI), etc was checked at postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Group I, SSNB & ANB Procedure: Group II, SSNB alone Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sono-guided Suprascapular Nerve Block Combined With Axillary Nerve Block in Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Group I, SSNB & ANB
21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (ANB) both with 10mL ropivacaine.
Procedure: Group I, SSNB & ANB
Suprascapular nerve block (SSNB) and axillary nerve block(ANB) were performed by one anesthesiologist under sono-guidance. 23 gauge spinal needle was used. SSNB was done at first and the entry site was the mid point between an anterolateral angle of acromion and medial end of scapular spine. With the linear probe, the suprascapular notch was identified and the block was performed penetrating the transverse scapular ligament because the scapular nerve and artery were located at the suprascapular notch. Just after the SSNB, ANB was performed and the entry site was the point 1.5 cm medial and 2cm inferior to posterolateral angle of acromion. With the linear probe, posterior circumflex artery was identified and the block was done at just above the artery.

Placebo Comparator: Group II, SSNB alone
The other 21 patients were allocated into group II, and received suprascapular nerve block (SSNB) with 10mL ropivacaine and axillary nerve block (ANB) with placebo (10mL normal saline).
Procedure: Group II, SSNB alone
This is same as the Group I, SSNB & ANB, but ANB was performed with placebo(10mL normal saline).




Primary Outcome Measures :
  1. Visual analogue pain scale [ Time Frame: postoperative 48 hours ]
    VAS pain score was selected from 0 to 10. 0 was no pain and 10 was severe pain that the patient had ever experienced.


Secondary Outcome Measures :
  1. Patient satisfaction (SAT) [ Time Frame: postoperative 48 hours ]
    SAT was also selected from 0 to 10. 0 was unsatisfactory and 10 was very satisfactory.


Other Outcome Measures:
  1. lateral pain index (LPI) [ Time Frame: postoperative 48 hours ]
    The percentage of lateral pain was determined as a value between 0 and 100. LPI was determined as VAS pain score × the percentage of lateral pain of shoulder ÷ 100.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. an definite rotator cuff tear on preoperative MRI which needed repair,
  2. accept an arthroscopic surgery including rotator cuff repair,
  3. more than 20 years old,
  4. accept preemptive regional block and PCA (patient controlled analgesia).

Exclusion Criteria:

  1. did not underwent arthroscopic rotator cuff repair
  2. stopped PCA before postoperative 48 hours due to associated side effect
  3. history of previous shoulder operation or fracture,
  4. a concomitant neurologic disorder around the shoulder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060812


Locations
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Korea, Republic of
Chuncheon Sacred Heart Hospital
Chuncheon-si, Gangwon-do, Korea, Republic of, 700-204
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Principal Investigator: Jung-Taek Hwang, MD, PhD Chuncheon Sacred Heart Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jung-Taek Hwang, Assistant professor in department of orthopedic surgery, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02060812     History of Changes
Other Study ID Numbers: SSNB&ANB
Chuncheon1 ( Other Identifier: Chuncheon )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Jung-Taek Hwang, Chuncheon Sacred Heart Hospital:
ultrasound guided axillary nerve block
arthroscopic rotator cuff repair
ultrasound guided suprascapular nerve block
rebound phenomenon of pain

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries