A Novel Selective Block of the Suprascapular Nerve

This study has been completed.
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Lars Marius Ytrebo, University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT02035774
First received: January 12, 2014
Last updated: June 16, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Selective Block of the Suprascapular Nerve

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Wrist angle [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)


Secondary Outcome Measures:
  • Satisfaction score [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 12, 2014
Last Updated: June 16, 2014
Health Authority: Norway: Ethics Committee

Keywords provided by University Hospital of North Norway:
Brachial plexus block
Suprascapular nerve block

Additional relevant MeSH terms:
Wounds and Injuries
Fractures, Bone
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014