A Novel Selective Block of the Suprascapular Nerve

Fracture Clinical Trial

Official title:

A Novel Selective Block of the Suprascapular Nerve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035774
• Other study ID #: SSNB
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2014
• Last updated: June 16, 2014
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of the hand. The investigators think that this supination is caused by lateral rotation in the shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal positioning of the hand for surgery on the dorsal side of the hand may be achieved by performing a SSN block (SSNB) in addition to the LSIB.

Description:

According to the hypothesis the investigators will perform a double blind , placebo controlled study to answer the research question above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with American Society of Anesthesiologists physical status (ASA) I- III

• age between 18 and 70 years

• body mass index between 20 and 36 kg/m2 scheduled for elective hand surgery.

Exclusion Criteria:

We will measure the angle between wrist and horizontal plane while the patient is supine and the extended arm 75° abducted.

• Patient who are not able to pronate the hand =15° before block performance, will be excluded from the study.

• Patients will also be excluded if they are pregnant, have contraindications to regional anesthesia, coagulation disorder, allergy to local anesthetics (LA), atrioventricular block, peripheral neuropathy or drug-treated diabetes.

• Patients using other anticoagulation drugs than acetylsalicylic acids or dipyridamol will be excluded.

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

• Fracture
• Ligament Injury

Intervention

Procedure:
• LSIB + SSNB
Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) or LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml placebo, saline)

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Hackworth RJ. A new and simplified approach to target the suprascapular nerve with ultrasound. J Clin Anesth. 2013 Jun;25(4):347-8. doi: 10.1016/j.jclinane.2013.01.006. Epub 2013 May 1. — View Citation

Siegenthaler A, Moriggl B, Mlekusch S, Schliessbach J, Haug M, Curatolo M, Eichenberger U. Ultrasound-guided suprascapular nerve block, description of a novel supraclavicular approach. Reg Anesth Pain Med. 2012 May-Jun;37(3):325-8. doi: 10.1097/AAP.0b013e3182409168. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrist angle	The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)	30 minutes	No
Secondary	Satisfaction score	The investigators will ask the surgeons about his/her satisfaction with the hand position during surgery.	3 hours	No