Axillary Nerve Block Combined With Suprascapular Nerve Block (SSNBANB)
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Group I, SSNB & ANB
Group II, SSNB alone
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring ultrasound guided axillary nerve block, arthroscopic rotator cuff repair, ultrasound guided suprascapular nerve block, rebound phenomenon of pain
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Chuncheon Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group I, SSNB & ANB
Group II, SSNB alone
Arm Description
21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (ANB) both with 10mL ropivacaine.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient satisfaction (SAT)
SAT was also selected from 0 to 10. 0 was unsatisfactory and 10 was very satisfactory.
Full Information
NCT ID
NCT02060812
First Posted
February 10, 2014
Last Updated
February 11, 2014
Sponsor
Chuncheon Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02060812
Brief Title
Axillary Nerve Block Combined With Suprascapular Nerve Block
Acronym
SSNBANB
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
ultrasound guided axillary nerve block, arthroscopic rotator cuff repair, ultrasound guided suprascapular nerve block, rebound phenomenon of pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I, SSNB & ANB
Arm Type
Experimental
Arm Description
21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (ANB) both with 10mL ropivacaine.
Arm Title
Group II, SSNB alone
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Group I, SSNB & ANB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group II, SSNB alone
Intervention Description
This is same as the Group I, SSNB & ANB, but ANB was performed with placebo(10mL normal saline).
Primary Outcome Measure Information:
Title
Visual analogue pain scale
Description
VAS pain score was selected from 0 to 10. 0 was no pain and 10 was severe pain that the patient had ever experienced.
Time Frame
postoperative 48 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction (SAT)
Description
SAT was also selected from 0 to 10. 0 was unsatisfactory and 10 was very satisfactory.
Time Frame
postoperative 48 hours
Other Pre-specified Outcome Measures:
Title
lateral pain index (LPI)
Description
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.
Time Frame
postoperative 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Taek Hwang, MD, PhD
Organizational Affiliation
Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon-si
State/Province
Gangwon-do
ZIP/Postal Code
700-204
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24880194
Citation
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.
Results Reference
derived
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Axillary Nerve Block Combined With Suprascapular Nerve Block
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