NCT01229683

Brief Summary

Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

October 27, 2010

Last Update Submit

March 6, 2012

Conditions

Keywords

UCSDPerineural Nerve BlockShoulder SurgeryPainGrip StrengthSensationInterscalene Nerve Block

Study Arms (1)

Shoulder Surgery

Patients will be given an interscalene nerve block and then strength and sensation of the hand and forearm will be tested to determine if the block is helping to anesthetize these areas.

Procedure: Interscalene Nerve Block

Interventions

Patients undergoing shoulder surgery will be given an Interscalene Nerve Block. The patients' strength and sensation in their hand and forearm will be tested to determine if the nerve block is affectively delivering anesthetic to the nerves that serve these areas.

Shoulder Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will consist only of patients undergoing orthopedic shoulder surgery.

You may qualify if:

  • years of age or older
  • unilateral orthopedic shoulder surgery
  • already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine

You may not qualify if:

  • any known contraindication to study medications or testing hand grip strength pre/post-op
  • insulin-dependent diabetes mellitus
  • neuropathy of any etiology in the affected extremity
  • any anticipated incision site apart from the shoulder
  • Obesity
  • Pregnancy
  • Incarceration
  • inability to communicate with the investigators and hospital staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Centers (Hillcrest and Thornton)

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian M Ilfeld, M.D., M.S.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, In Residence

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 28, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

March 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations