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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01958801
Other study ID # CR-13-033
Secondary ID
Status Completed
Phase N/A
First received October 7, 2013
Last updated April 6, 2014
Start date September 2013
Est. completion date March 2014

Study information

Verified date April 2014
Source Daegu Catholic University Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.


Description:

This study aims to compare supraclavicular brachial plexus block to interscalene brachial plexus block with regard to degree of sensory and motor blockades, side effects and complications of the blocks, and frequency of intraoperative analgesics or antihypertensives use.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 80 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists physical status I-II

- Body mass index < 35 kg/m2

Exclusion Criteria:

- Neurologic deficits on the side to be blocked

- Infection or inflammation at the puncture site for brachial plexus block

- Psychiatric disorders

- Patient refusal

- Difficulty to communicate

- Coagulation deficiencies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Supraclavicular block
Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
Interscalene block
Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.

Locations

Country Name City State
Korea, Republic of Daegu Catholic University Medical Center Daegu

Sponsors (1)

Lead Sponsor Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Conroy PH, Awad IT. Ultrasound-guided blocks for shoulder surgery. Curr Opin Anaesthesiol. 2011 Dec;24(6):638-43. doi: 10.1097/ACO.0b013e32834c155f. 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 Degree of sensory blockade Sensory blockade of the C5 to T1 dermatomes was assessed by rating the absence of cold sensation between 100 (intact sensation) and 0 (no sensation) with an alcohol swab. 20 minutes after the end of local anesthetics injection No
Secondary Degree of motor blockade Motor blockade was evaluated by elbow and wrist extension (radial nerve), finger abduction (ulnar nerve), wrist flexion (median nerve), and elbow flexion (musculocutaneous nerve). The muscle force was rated on a scale of 0 to 6 as follows (6: normal muscle force; 5: slightly reduced muscle force; 4: greatly reduced muscle force; 3: slightly impaired mobility; 2: greatly impaired mobility; 1: near complete paralysis; 0: complete paralysis). 20 minutes after the end of local anethetics injection No
Secondary Side effects Horner's syndrome (ptosis, miosis, anhidrosis) Subjective dyspnea Hoarseness 20 minutes after the end of local anethetics injection No
Secondary Frequency of intraoperative analgesics or antihypertensives use Frequency of intraoperative use of opioids (fentanyl) or antihypertensives (hydralazine) At the end of the surgery No
See also
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