Effect of Interscalene Block on Ventilatory Function

Respiratory Depression Clinical Trial

— KTBIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740453
• Other study ID #: KTBIS-2012-V1
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2012
• Last updated: January 16, 2015
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: January 2015
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia Morbidity
• Block
• Respiratory Depression
• Respiratory Insufficiency

Intervention

Drug:
• ropivacaine 2 mg/ml
single

Locations

Country	Name	City	State
France	Centre hospitalier La Pitié Salpetriere	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of sensory interscalene block	outcome measure was performed using a cold test on the skin	Day 2	No
Primary	Reduction of the pulmonary forced vital capacity	A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer	Day 2	No
Secondary	Reduction of the pulmonary maximum forced expiratory flow	Outcome measure was performed using a spirometer	Day 2	No
Secondary	Morphine consumption	Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)	Day 2	No
Secondary	Pain score at rest and motion	Outcome Measure using a visual analog scale (0 to 10)	Day 2	No