NCT01740453

Brief Summary

Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (\< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

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, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

November 26, 2012

Last Update Submit

January 16, 2015

Conditions

Respiratory DepressionAnesthesia MorbidityBlock

Outcome Measures

Primary Outcomes (1)

  • Reduction of the pulmonary forced vital capacity

    A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer

    Day 2

Secondary Outcomes (3)

  • Reduction of the pulmonary maximum forced expiratory flow

    Day 2

  • Morphine consumption

    Day 2

  • Pain score at rest and motion

    Day 2

Other Outcomes (1)

  • Duration of sensory interscalene block

    Day 2

Study Arms (2)

Single (no catheter)

NO INTERVENTION

ropivacaine single injection : 5 mg/ml 15 ml

Continuous infusion

EXPERIMENTAL

Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h

Drug: ropivacaine 2 mg/ml

Interventions

ropivacaine 2 mg/mlDRUG

single

Continuous infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgery : scheduled for elective shoulder surgery
  • available for 1 month of follow up
  • physical status : 1, 2, 3

You may not qualify if:

  • body mass index \> 35
  • contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
  • vital capacity less than 1.5 liters
  • cardiac or renal insufficiency
  • physical status \>3, pregnant, weigh less than 50 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier La Pitié Salpetriere

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Respiratory InsufficiencyBites and Stings

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Philippe Cuvillon, Md,PhD

    Caremeau Hospital, Nimes, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 4, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

FR(1)