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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02014766
Other study ID # Inter1
Secondary ID 2013-M10
Status Recruiting
Phase N/A
First received December 6, 2013
Last updated December 12, 2013
Start date November 2013
Est. completion date December 2014

Study information

Verified date December 2013
Source Cheju Halla General Hospital
Contact Chunwoo Yang, MD
Phone 82-10-2670-0520
Email everycw@daum.net
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Interventional

Clinical Trial Summary

We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.


Description:

Interscalene block provides effective postoperative analgesia after shoulder surgery. However, it can be associated with significant risk including the phrenic nerve palsy. Previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

American Society of Anesthesiologists physical status I-III inpatients undergoing shoulder surgery

Exclusion Criteria:

pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Interscalene block
Ultrasound-guided interscalene block is performed.
Supraclavicular block
Ultrasound-guided supraclavicular block is performed

Locations

Country Name City State
Korea, Republic of Cheju Halla General Hopsital Jeju Jeju self-governing province

Sponsors (1)

Lead Sponsor Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-24. doi: 10.1111/j.1365-2044.2009.06231.x. Review. — View Citation

Liu SS, Gordon MA, Shaw PM, Wilfred S, Shetty T, Yadeau JT. A prospective clinical registry of ultrasound-guided regional anesthesia for ambulatory shoulder surgery. Anesth Analg. 2010 Sep;111(3):617-23. doi: 10.1213/ANE.0b013e3181ea5f5d. Epub 2010 Aug 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain duration at 24h after operation No
Secondary diaphragmatic movement preoperative, after block(at 30 min), after operation No
Secondary motor block after block(at 30 min), after operation, at 24h No
Secondary paresthesia after block(at 30min), after operation, at 24h No
Secondary complications after block (at 30 min), after operation, at 24h No
Secondary supplemental analgesia after operation, at 24h No
Secondary pain score at 24h No
Secondary patient satisfaction at 24h No
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