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Effect of Interscalene Block on Ventilatory Function (KTBIS)

P

Pierre and Marie Curie University

Status and phase

Completed
Phase 4

Conditions

Block
Anesthesia Morbidity
Respiratory Depression

Treatments

Drug: ropivacaine 2 mg/ml

Study type

Interventional

Funder types

Other

Identifiers

NCT01740453
KTBIS-2012-V1

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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