Effect of Interscalene Block on Ventilatory Function

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740453

Acronym

KTBIS

Enrollment

Registered

2012-12-04

Start date

2012-01-31

Completion date

2012-03-31

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Morbidity, Block, Respiratory Depression

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.

Interventions

DRUGropivacaine 2 mg/ml

single

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
Duration of sensory interscalene block	Day 2	outcome measure was performed using a cold test on the skin

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026