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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02809144
Other study ID # 0472
Secondary ID
Status Completed
Phase N/A
First received May 25, 2015
Last updated December 5, 2016
Start date April 2016
Est. completion date November 2016

Study information

Verified date December 2016
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority Norway: Ministry of Health and Care Services
Study type Interventional

Clinical Trial Summary

Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.


Description:

Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.

Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients scheduled for shoulder surgery.

- American Society of Anesthesiologist grad I-III,

- 18-70 years,

- BMI 20-35,

Exclusion Criteria:

- Pregnancy,

- coagulopathy,

- allergy to local anesthetics,

- atrioventricular block,

- peripheral neuropathy or drug-treated diabetes.

- Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Nerve block
Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The need for general anaesthesia Investigators will record the number of patients who need to be converted to general anaesthesia Intraoperatively No
Secondary Surgeons satisfaction with the working conditions Graded in a) Good and b) Poor Intraoperatively No
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