Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

NCT02424630 | Completed Results DMC

• 1 other identifier: 2013-52
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rotator Cuff Injury

Keywords

sono-guided interscalene brachial plexus block; arthroscopy-guided suprascapular nerve block; arthroscopic rotator cuff repair; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Satisfaction (SAT) Score

  1, 3, 6, 12, 18, 24, 36, 48h

Study Arms (2)

ISB with SSNB

EXPERIMENTAL

During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.

Device: Ultrasound-guided ISB; Device: Arthroscopy-guided SSNB; Drug: Placebo; Drug: Ropivacaine

ISB alone

PLACEBO COMPARATOR

During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.

Device: Ultrasound-guided ISB; Drug: Placebo

Interventions

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.

ISB alone; ISB with SSNB

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.

ISB with SSNB

Placebo DRUG

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

ISB alone; ISB with SSNB

Ropivacaine DRUG

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

ISB with SSNB

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Hallym University: collaborator

Related Publications (1)

• Lee JJ, Hwang JT, Kim DY, Lee SS, Hwang SM, Lee NR, Kwak BC. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2121-2128. doi: 10.1007/s00167-016-4198-7. Epub 2016 Jun 16.

  PMID: 27311449 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr Jung-Taek Hwang
• Organization: Chuncheon Sacred Heart Hospital

drakehjt@hanmail.net

82 33 240 5197

Study Officials

• Jung-Taek Hwang, MD, PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 23, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 27, 2020
• Results First Posted: August 27, 2020

Record last verified: 2020-08