Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery

• Sponsor: Daegu Catholic University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01958801
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Horner's Syndrome	Other: Supraclavicular block; Other: Interscalene block	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Comparison Between Ultrasound-guided Supraclavicular and Interscalene Brachial Plexus Blocks in the Patients Undergoing Arthroscopic Shoulder Surgery
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interscalene block Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, nerve stimulation needle is advanced into the brachial plexus sheath, into which 25 ml of 1.5% mepivacaine is injected.	Other: 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.
Experimental: Supraclavicular block Supraclavicular block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral supraclavicular fossa visualizing the brachial plexus located lateral to the subclavian artery. Using in-plane technique, nerve stimulation needle is advanced into the brachial plexus sheath, into which 25 ml of 1.5% mepivacaine is injected.	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.

Outcome Measures

Primary Outcome Measures

1. Degree of sensory blockade [20 minutes after the end of local anesthetics injection]

   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.

Secondary Outcome Measures

1. Degree of motor blockade [20 minutes after the end of local anethetics injection]

   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).

2. Side effects [20 minutes after the end of local anethetics injection]

   Horner's syndrome (ptosis, miosis, anhidrosis) Subjective dyspnea Hoarseness

3. Frequency of intraoperative analgesics or antihypertensives use [At the end of the surgery]

   Frequency of intraoperative use of opioids (fentanyl) or antihypertensives (hydralazine)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daegu Catholic University Medical Center	Daegu		Korea, Republic of	705-718

Sponsors and Collaborators

• Daegu Catholic University Medical Center

Investigators

• Principal Investigator: JongHae Kim, Master, Daegu Catholic University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: JongHae Kim, Assistant Professor, Daegu Catholic University Medical Center
• ClinicalTrials.gov Identifier: NCT01958801
• Other Study ID Numbers: CR-13-033
• First Posted: Oct 9, 2013
• Last Update Posted: Apr 8, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by JongHae Kim, Assistant Professor, Daegu Catholic University Medical Center: Supraclavicular brachial plexus block; Interscalene brachial plexus block; Arthroscopic shoulder surgery
• Additional relevant MeSH terms: Horner Syndrome

Study Results

No Results Posted as of Apr 8, 2014