NCT01740453

CompletedPhase 4

Effect of Interscalene Block on Ventilatory Function

Pierre and Marie Curie University Source

Pierre and Marie Curie University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

KTBIS-2012-V1

Study Type

interventional

Actual enrollment (reported)

70

Locations

1 country

Sites

1

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2012

Actual (reported)

Study Completion

March 2012

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 70 participants
Study completion date: March 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)
Study Completion
March 2012
Actual (reported)
First Submitted
November 26, 2012
Actual (reported)
First Posted
December 4, 2012
Actual (reported)

Last Updated: January 19, 2015
Status Verified: January 2015
Last Update Submitted: January 16, 2015

Conditions

Respiratory Depression Anesthesia Morbidity Block

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

Sponsors & Collaborators

Pierre and Marie Curie University
Otherlead

Study Sites (1)

Centre hospitalier La Pitié Salpetriere

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

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

Enrollment

70 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 4Completed

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Phase 4Completed

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Phase 4Terminated

NCT01843153

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Phase 4Completed

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.

Primary Completion

March 2012

Actual (reported)

Study Completion

March 2012

Actual (reported)

Last Updated

January 19, 2015

Record last verified: 2015-01

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01740453
Data provider: ClinicalTrials.gov
Source updated: 2015-01-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:58 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (2)

Single (no catheter)

Continuous infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations