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Rotator Cuff TearSSNBANBNCT02060812

Axillary Nerve Block Combined With Suprascapular Nerve Block

A study testing Group I, SSNB & ANB and Group II, SSNB alone in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rotator Cuff Tear
What is being tested?
Group I, SSNB & ANB and Group II, SSNB alone
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteSouth Korea
Study dates
Nov 2012to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 700-204

Other trials in South Korea

About this study

Official title: The Effect of Sono-guided Suprascapular Nerve Block Combined With Axillary Nerve Block in Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

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.

Read the detailed description

All procedures described in the present study were approved by the Institutional Review Board of our hospital, and all patients gave written informed consent to participate in the present study. Between November 2012 and July 2013, forty-two patients with rotator cuff tear who had undergone arthroscopic rotator cuff repairs were enrolled in this study. Rotator cuff tears were diagnosed by use of preoperative magnetic resonance imaging (MRI), and the size of a rotator cuff was confirmed at the time of arthroscopic operation. Indication for surgery was symptomatic full thickness rotator cuff tear or partial thickness rotator cuff more than 50% thickness in case of failed conservative therapy. Among them, 21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (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.

For the cases in this study, the inclusion criteria were (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 patient controlled analgesia (PCA). Some patients were excluded for the following reasons (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

Visual analogue scale (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) shoulder score, Constant score, height, and weight, etc were checked preoperatively. All the regional blocks were preemptively performed under sono-guidance. PCA was set at the fixed dose (0.05 ug/kg of loading dose and 0.03ug/min.kg of continuous dose, fentanyl) to remove the effect of variable amount of PCA. VAS pain score, patient's satisfaction (SAT), the percentage of lateral pain of affected shoulder, and Lateral Pain Index (LPI: VAS × the percentage of lateral pain of shoulder ÷ 100) was checked postoperative 1, 3, 6, 12, 18, 24, 36, and 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.1 SAT was also selected from 0 to 10. 0 was unsatisfactory and 10 was very satisfactory. 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. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.

Power analysis indicated that a total sample size of 34 patients (17 patients in each cohort) would provide a statistical power of 99% with a 2-sided α level of .05 to detect significant differences in VAS at postoperative 6 hours, assuming an effect size of 1.56 (mean difference: 2.5, standard deviation: 1.6). This was based on the mean and standard deviation of VAS at postoperative 6 hours observed in a pilot study of 20 patients. Double blinded randomization was performed as follows. The 48 patients who had met the inclusion criteria were randomly assigned to 1 of 2 groups depending on the combined ANB. Randomization was performed with a computer random sequence generator by an independent nurse, who prepared a syringe for combined ANB according to the assignment. The patient and all the medical staff who participated in the operation were blinded of the assignment. After this study, according to the exclusion criteria, two patient with no rotator cuff tear and three patient with only rotator cuff fraying who underwent only arthroscopic debridement were excluded from this study. One patient who stopped PCA at postoperative 1 hour was done, too. In the end, the 42 patients were included in this study. Among them, 21 patients belonged to group I, and the other 21 patients belonged to group II.

All the regional blocks were preemptively performed. When the patient was positioned in beach chair position, SSNB and ANB were performed by one anesthesiologist under sono-guidance. 23 gauge spinal needle was used. Just after skin preparation using povidone Iodine solution, a thin layer of sterile ultrasound transmission gel was placed between the ultrasound transducer and the skin. 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 parallel to the scapular spine, 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 parallel to the longitudinal axis of the humerus, posterior circumflex artery was identified and the block was done at just above the artery. The color Doppler sonography may be helpful for identifying the arterial structures, but they were sometimes undetectable, and therefore they could be identified by detecting a pulsatile motion.

All the patients in this study underwent arthroscopic rotator cuff repair and subacromial decompression. All procedures were performed by one surgeon who had specialized in shoulder and elbow surgery, and sports medicine. Four routine arthroscopic portals (anterior, posterior, lateral, and posterolateral) were used in arthroscopic surgery. After bursectomy, arthroscopic subacromial decompression was performed with acromioplasty and spur removal in all patients. Suture bridge technique was mainly used for rotator cuff repair with 5.0mm Bio-Corkscrew suture anchor (Arthrex, Naples, Florida, USA) and 4.75mm Bio-SwiveLock (Arthrex, Naples, Florida, USA). Tendon to tendon suture was sometimes used for small to medium tear located around musculotendinous junction. According to the concomitant diseases, long lead of biceps (LHB) tenotomy or tenodesis, distal clavicle resection, and anterior capsulotomy were performed simultaneously.

Postoperatively, a shoulder-immobilizing sling with an abduction pillow was prescribed to each patient. The postoperative rehabilitation was individualized according to the size of rotator cuff tear and the tissue quality of torn rotator cuff. The patients without a rotator cuff tear were allowed passive forward elevation using a pulley at postoperative 48 hours just after PCA had been removed.

The normally distributed data between the groups was analyzed using a t test for independent samples. Otherwise, a nonparametric Mann-Whitney U test. Probable factors which might affect rebound of pain were analyzed using univariate logistic regression. Statistical analysis was performed using the SPSS 13.0 (SPSS Inc, Chicago, Illinois, U.S.A.). The significance level was set at P<.05.

Being tested
Group I, SSNB & ANB, Group II, SSNB alone
Keywords
ultrasound guided axillary nerve block, arthroscopic rotator cuff repair, ultrasound guided suprascapular nerve block, rebound phenomenon of pain
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group I, SSNB & ANBProcedure or surgery

    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.

  • Group II, SSNB aloneProcedure or surgery

    This is same as the Group I, SSNB \& ANB, but ANB was performed with placebo(10mL normal saline).

Study groups in NCT02060812
Study groupRoleWhat they receive
Group I, SSNB & ANBExperimental21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (ANB) both with 10mL ropivacaine.
Receives: Procedure: Group I, SSNB & ANB
Group II, SSNB alonePlacebo comparatorThe 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).
Receives: Procedure: Group II, SSNB alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue pain scale

    VAS pain score was selected from 0 to 10. 0 was no pain and 10 was severe pain that the patient had ever experienced.

    Measured: postoperative 48 hours

Secondary outcomes (1)
  1. Patient satisfaction (SAT)

    SAT was also selected from 0 to 10. 0 was unsatisfactory and 10 was very satisfactory.

    Measured: postoperative 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2014 (estimated)
  2. Study startNov 2012
  3. Primary completionJul 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060812
Sponsor's protocol ID
SSNB&ANB
Other IDs
Chuncheon1
Acronym
SSNBANB
Status last verified
Feb 2014
First submitted
10 Feb 2014
Last updated
12 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee JJ, Kim DY, Hwang JT, Lee SS, Hwang SM, Kim GH, Jo YG. Effect of ultrasonographically guided axillary nerve block combined with suprascapular nerve block in arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy. 2014 Aug;30(8):906-14. doi: 10.1016/j.arthro.2014.03.014. Epub 2014 May 29.

    PubMed 24880194

Questions about this trial

What is this clinical trial studying?

A study testing Group I, SSNB & ANB and Group II, SSNB alone in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue pain scale (time frame: postoperative 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.

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