Effect of Interscalene Block on Ventilatory Function | NCT01740453

Studies
Effect of Interscalene Block on Ventilatory Function

NCT01740453

Sponsor

Pierre and Marie Curie University

Status

Completed

Last Update Posted

Jan 19, 2015Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Respiratory Depression
Anesthesia Morbidity
Block

Interventions

ropivacaine 2 mg/ml

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Nov 26, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2015

Last Update Posted Date

Jan 19, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philippe Cuvillon, MD, PhD, Centre Hospitalier Universitaire de NīmesPrincipal Investigator

Lead Sponsor

Pierre and Marie Curie UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ropivacaine 2 mg/ml	Drug	single	Continuous infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Reduction of the pulmonary maximum forced expiratory flow	Outcome measure was performed using a spirometer	Day 2
Morphine consumption	Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)

Other Outcomes

Measure	Description	Time Frame
Duration of sensory interscalene block	outcome measure was performed using a cold test on the skin	Day 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Cuvillon, Md,PhD	Caremeau Hospital, Nimes, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier La Pitié Salpetriere		Paris	Île-de-France Region	75013	France

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D001733	Bites and Stings

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D011041	Poisoning
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided