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A Novel Selective Block of the Suprascapular Nerve

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035774
First Posted: January 14, 2014
Last Update Posted: June 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Lars Marius Ytrebo, University Hospital of North Norway
  Purpose
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.

Condition Intervention Phase
Ligament Injury Fracture Procedure: LSIB + SSNB Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Selective Block of the Suprascapular Nerve

Further study details as provided by Lars Marius Ytrebo, University Hospital of North Norway:

Primary Outcome Measures:
  • Wrist angle [ Time Frame: 30 minutes ]
    The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)


Secondary Outcome Measures:
  • Satisfaction score [ Time Frame: 3 hours ]
    The investigators will ask the surgeons about his/her satisfaction with the hand position during surgery.


Estimated Enrollment: 30
Study Start Date: January 2014
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LSIB +SSNB
Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml)
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)
Placebo Comparator: LSIB + placebo
Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml) + SSNB (4 ml saline)
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035774


Locations
Norway
University Hospital of North Norway
Tromsø, Troms, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
Principal Investigator: Lars M Ytrebø, Professor University Hospital of North Norway
  More Information

Publications:
Responsible Party: Lars Marius Ytrebo, Professor, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02035774     History of Changes
Other Study ID Numbers: SSNB
First Submitted: January 12, 2014
First Posted: January 14, 2014
Last Update Posted: June 17, 2014
Last Verified: June 2014

Keywords provided by Lars Marius Ytrebo, University Hospital of North Norway:
Brachial plexus block
Suprascapular nerve block

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents