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Completed

NCT Number: NCT02424630

Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

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.

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Key information

Conditions

Rotator Cuff Injury Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • definite rotator cuff tear on preoperative MRI, which needed repair;
  • acceptance of arthroscopic surgery including rotator cuff repair;
  • > 20 years old; and
  • acceptance of routine regional blocks and patient-controlled analgesia.

Exclusion criteria

  • did not want arthroscopic rotator cuff repair;
  • stopped PCA before 48 h postoperatively due to side effects;
  • history of shoulder operation or fracture;
  • concomitant neurological disorder around the shoulder;
  • conversion to open surgery from the arthroscopy; and
  • contraindication to the routine regional blocks in this study

Treatment and study plan

Ultrasound-guided ISB

Device

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

Device

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.

Placebo

Drug

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

Ropivacaine

Drug

All the regional blocks in this study were performed using 10mL ropivacaine.

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Score

    Time frame: 1, 3, 6, 12, 18, 24, 36, 48h

    The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain

Secondary outcomes

  1. Patient Satisfaction (SAT) Score

    Time frame: 1, 3, 6, 12, 18, 24, 36, 48h

    The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Hallym University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2015
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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