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A Novel Selective Block of the Suprascapular Nerve

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ClinicalTrials.gov Identifier: NCT02035774
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Lars Marius Ytrebo, University Hospital of North Norway

January 12, 2014
January 14, 2014
June 17, 2014
January 2014
June 2014   (Final data collection date for primary outcome measure)
Wrist angle [ Time Frame: 30 minutes ]
The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)
Same as current
Complete list of historical versions of study NCT02035774 on ClinicalTrials.gov Archive Site
Satisfaction score [ Time Frame: 3 hours ]
The investigators will ask the surgeons about his/her satisfaction with the hand position during surgery.
Same as current
Not Provided
Not Provided
 
A Novel Selective Block of the Suprascapular Nerve
A Novel Selective Block of the Suprascapular Nerve
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.
According to the hypothesis the investigators will perform a double blind , placebo controlled study to answer the research question above.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ligament Injury
  • Fracture
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)
  • Active Comparator: LSIB +SSNB
    Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml)
    Intervention: Procedure: LSIB + SSNB
  • Placebo Comparator: LSIB + placebo
    Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml) + SSNB (4 ml saline)
    Intervention: Procedure: LSIB + SSNB

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT02035774
SSNB
No
Not Provided
Not Provided
Lars Marius Ytrebo, University Hospital of North Norway
University Hospital of North Norway
University of Tromso
Principal Investigator: Lars M Ytrebø, Professor University Hospital of North Norway
University Hospital of North Norway
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP