Effect of Interscalene Block on Ventilatory Function

Phase 4

Completed

• Conditions: Respiratory Depression; Anesthesia Morbidity; Block
• Interventions: Drug: ropivacaine 2 mg/ml

• Registration Number: NCT01740453
• Lead Sponsor: Pierre and Marie Curie University

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	ropivacaine 2 mg/ml	Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Centre hospitalier La Pitié Salpetriere; 🇫🇷 Paris, Ile de France, France