Effect of Interscalene Block on Ventilatory Function

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01740453
• Date of registration: 26/11/2012
• Prospective Registration: No
• Primary sponsor: Pierre and Marie Curie University
• Public title: Effect of Interscalene Block on Ventilatory Function KTBIS
• Scientific title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
• Date of first enrolment: January 2012
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01740453
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Philippe Cuvillon, Md,PhD
• Affiliation: Caremeau Hospital, Nimes, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Block

Respiratory Depression

Anesthesia Morbidity

Intervention(s)

Drug: ropivacaine 2 mg/ml

Primary Outcome(s)

Reduction of the pulmonary forced vital capacity [Time Frame: Day 2]

Secondary Outcome(s)

Reduction of the pulmonary maximum forced expiratory flow [Time Frame: Day 2]

Pain score at rest and motion [Time Frame: Day 2]

Morphine consumption [Time Frame: Day 2]

Secondary ID(s)

KTBIS-2012-V1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors