NCT02879916

Brief Summary

This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.

Trial Health

100
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 Oct 2011

Longer than P75 for phase_4

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

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

August 11, 2016

Last Update Submit

October 26, 2016

Conditions

Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia

    The duration of analgesia assessed with quantitative sensory testing

    24 hours

Secondary Outcomes (2)

  • Need for rescue analgesia

    24 hours

  • Duration of motor block

    24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

NaCl 0.9% 3ml perineural stellate ganglion injection

Drug: NaCl 0.9%

Stellate ganglion block

ACTIVE COMPARATOR

Levobupivacaine 3ml perineural stellate ganglion injection

Drug: Levobupivacaine

Interventions

LevobupivacaineDRUG

Inject 3ml of levobupavacaine into the stellate ganglion area

Stellate ganglion block
NaCl 0.9%DRUG

Inject 3ml of NaCl 0.9% into the stellate ganglion area

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class 1 to 3
  • Need for shoulder surgery

You may not qualify if:

  • Mental retardation
  • allergy for local anesthetics
  • a medical reason as a contra-indication for NSAID use
  • Diabetes mellitus
  • peripheral neuropathy
  • chronic analgetic use
  • chronic pain patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LevobupivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Luc Sermeus, MD

    Consultant

    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
research assistant

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 26, 2016

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

September 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share