KTBIS: Effect of Interscalene Block on Ventilatory Function

Sponsor

Pierre and Marie Curie University (Other)

Overall Status

Completed

CT.gov ID

NCT01740453

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

35.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Depression Anesthesia Morbidity Block	Drug: ropivacaine 2 mg/ml	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Single (no catheter) ropivacaine single injection : 5 mg/ml 15 ml
Experimental: Continuous infusion Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h	Drug: ropivacaine 2 mg/ml single

Arm

Intervention/Treatment

No Intervention: Single (no catheter)

ropivacaine single injection : 5 mg/ml 15 ml

Experimental: Continuous infusion

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

Drug: ropivacaine 2 mg/ml

single

Outcome Measures

Primary Outcome Measures

Reduction of the pulmonary forced vital capacity [Day 2]
A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer

Secondary Outcome Measures

Reduction of the pulmonary maximum forced expiratory flow [Day 2]
Outcome measure was performed using a spirometer
Morphine consumption [Day 2]
Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)
Pain score at rest and motion [Day 2]
Outcome Measure using a visual analog scale (0 to 10)

Other Outcome Measures

Duration of sensory interscalene block [Day 2]
outcome measure was performed using a cold test on the skin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier La Pitié Salpetriere	Paris	Ile de France	France	75013

Sponsors and Collaborators

Pierre and Marie Curie University

Investigators

Principal Investigator: Philippe Cuvillon, Md,PhD, Caremeau Hospital, Nimes, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philippe Cuvillon, MD, PhD, Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01740453

Other Study ID Numbers:

KTBIS-2012-V1

First Posted:

Dec 4, 2012

Last Update Posted:

Jan 19, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Respiratory Insufficiency

Ropivacaine

Study Results

No Results Posted as of Jan 19, 2015