NCT01877330

Brief Summary

This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

December 12, 2012

Last Update Submit

March 17, 2020

Conditions

Shoulder ArthroscopyUltrasound-guided Interscalene Nerve Block

Keywords

shoulder arthroscopyultrasound guided nerve blockinterscalene nerve block

Outcome Measures

Primary Outcomes (1)

  • Onset of motor blockade

    Time to loss of shoulder abduction.

    1 hour from time of injection

Secondary Outcomes (8)

  • Patient Satisfaction Score

    24 hours

  • Opioid consumption

    24 hours

  • Quality of Nerve block

    24 hours

  • Incidence of post-operative nausea/vomiting

    24 hours

  • Duration of nerve block

    24 hours

  • +3 more secondary outcomes

Study Arms (2)

Injection in interscalene groove

ACTIVE COMPARATOR

Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves.

Procedure: Interscalene block for shoulder arthroscopy

Injection between nerve roots

ACTIVE COMPARATOR

Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots.

Procedure: Interscalene block for shoulder arthroscopy

Interventions

Interscalene block for shoulder arthroscopyPROCEDURE
Injection between nerve rootsInjection in interscalene groove

Eligibility Criteria

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

You may not qualify if:

  • chronic pain
  • high preoperative opioid requirement
  • age \< 18 years old
  • non-English speaking
  • contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
  • need for postoperative nerve function monitoring
  • patient refusal
  • dementia
  • pulmonary disease or low baseline oxygen saturation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

Location

Study Officials

  • Pedram Aleshi, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Monica W Harbell, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

June 13, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

US(1)