Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

Rotator Cuff Injury Clinical Trial

Official title:

The Effect of Sono-Guided Interscalene Brachial Plexus Block Combined With Arthroscopy-Guided Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424630
• Other study ID #: 2013-52
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.

Description:

Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. definite rotator cuff tear on preoperative MRI, which needed repair;

2. acceptance of arthroscopic surgery including rotator cuff repair;

3. > 20 years old; and

4. acceptance of routine regional blocks and patient-controlled analgesia.

Exclusion Criteria:

1. did not want arthroscopic rotator cuff repair;

2. stopped PCA before 48 h postoperatively due to side effects;

3. history of shoulder operation or fracture;

4. concomitant neurological disorder around the shoulder;

5. conversion to open surgery from the arthroscopy; and

6. contraindication to the routine regional blocks in this study

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Injury

Intervention

Device:
• Ultrasound-guided ISB
ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
• Arthroscopy-guided SSNB
At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment.

Drug:
• Placebo
All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline)
• Ropivacaine
All the regional blocks in this study were performed using 10mL ropivacaine.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Hallym University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Score	The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain	1, 3, 6, 12, 18, 24, 36, 48h
Secondary	Patient Satisfaction (SAT) Score	The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.	1, 3, 6, 12, 18, 24, 36, 48h