Skip to main content

Table 1 Participant timeline of REDOLEV-2019 Clinical Trial

From: Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study

 

Study period

Enrolment

IBPB

Post-allocation

Close-out

Timepoint

Before surgery

0

4 h

24 h

30 days

Enrolment:

Eligibility screen

X

    

Informed consent

X

    

Medical background

X

    

Random Allocation

X

    

Interventions:

G1: IBPB 20 ml

 

X

   

G2: IBPB 10 ml

 

X

   

Assessments:

US: DTR, ED (n°esp) and ED (type)

X

 

X

  

Spirometry (FVC and FEV1)

X

 

X

X

 

Pain: 24 h total consumption and time to first request.

  

X

X

 

Complications

  

X

X

X

  1. This template is copyrighted by the SPIRIT Group. Abbreviations: DE diaphragmatic excursion, DTR diaphragmatic thickness ratio, FVC forced vital capacity, FEV1 forced expiratory volume at 1 s, IBPB interscalene brachial plexus block