NCT02035774

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

January 12, 2014

Last Update Submit

June 16, 2014

Conditions

Ligament InjuryFracture

Keywords

Brachial plexus blockSuprascapular nerve block

Outcome Measures

Primary Outcomes (1)

  • Wrist angle

    The investigators will assess the wrist angle 30 minutes after the two blocks (LSIB + SSNB)

    30 minutes

Secondary Outcomes (1)

  • Satisfaction score

    3 hours

Study Arms (2)

LSIB +SSNB

ACTIVE COMPARATOR

Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml)

Procedure: LSIB + SSNB

LSIB + placebo

PLACEBO COMPARATOR

Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml) + SSNB (4 ml saline)

Procedure: LSIB + SSNB

Interventions

LSIB + SSNBPROCEDURE

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)

LSIB + placeboLSIB +SSNB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related 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. No abstract available.

    PMID: 23643887BACKGROUND

  • 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.

    PMID: 22222688BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Lars M Ytrebø, Professor

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2014

First Posted

January 14, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

NO(1)