Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03688724 |
| Other study ID # |
ROV-DPOCUS-2018-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2018 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Hospital General Universitario de Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
It is a prospective observational study of a cohort of patients who underwent brachial plexus
blockage above the clavicle, and in which diaphragmatic function is observed in both
hemidiaphragms by ultrasound (using Diaphragm Thickening Fraction), which allows to obtain
the real incidence of Hemidiaphragm palsy in these patients, and estimate the perioperative
evolution of both hemidiaphragms.
Hemidiaphragm palsy after brachial plexus block above the clavicle (BPBAC) is frequent, but
few patients develop postoperative pulmonary complications (PPC). Little attention has been
paid to the contralateral hemidiaphragm as part of the global diaphragmatic function. After
BPBAC, global diaphragm function reduces due to ipsilateral hemidiaphragm reduction, but less
than expected due to the increase in the contralateral hemidiaphragm function. As a part of
the diaphragm function, the contralateral hemidiaphragm function plays a relevant role in the
appearance of PPC.
Description:
INTRODUCTION Shoulder surgery is known to be a particularly painful stimulus. Perioperative
analgesia using brachial plexus block by injection above the clavicle (BPBAC) for shoulder
surgery is the standard of care 1,2.
Up to date, ipsilateral diaphragmatic paresis after BPBAC is still very frequent, but few
patients develop postoperative pulmonary complications (PPC), and most of them are mild8.
There is much concern in avoiding ipsilateral hemidiaphragmatic paralysis to reduce PPC.
Little attention has been paid to the contralateral diaphragm and the global diaphragmatic
function formed by both hemidiaphragms (the ipsilateral and the contralateral to the BPBAC).
A meticulous study of perioperative diaphragm evolution is needed to answer why some patients
after BPBAC develop PPC and others do not.
OUTCOMES The primary objective was to examine the evolution of perioperative hemidiaphragm
function with ultrasound (ipsilateral and contralateral) when using BPBAC following shoulder
surgery.
the hypothesis is that despite frequent acute ipsilateral hemidiaphragm paralysis after
BPBAC, the contralateral hemidiaphragm function increases and preserves global diaphragmatic
function in most patients.
METHODS A prospective observational cohort study evaluating perioperative (preoperative and
postoperative) diaphragm point-of-care ultrasound (D-POCUS) at an academic tertiary hospital
in Spain. Adults undergoing shoulder surgery with planned BPBAC (ISB or SCB) will be eligible
for inclusion. Patients planned for not receive BPBAC for any reason will be exclude.
Thickening diaphragm fraction (TF) and diaphragm excursion (DE) were measured in both
hemidiaphragms before BPBAC (at the preoperative time) and within 30 min after surgery (at
the postoperative time, at least 1 hour after BPBAC).
All measures will be repeated three times in each patient and by the same member of the
research team to reduce intra-observer and inter-observer variability. In addition, he will
be blinded to the side on which the BPBAC will be performed.
TF was calculated using the following formula: TF = (Tdi-Tde)/Tde x100 (%). TF ipsilateral
was the TF measured in the hemidiaphragm ipsilateral to the BPBAC. TF contralateral was the
TF measured in the hemidiaphragm contralateral to the BPBAC. TFglobal was the sum of both
hemidiaphragm TF to reflect the global diaphragm function. It was calculated using the
following formula: (TF Global = (TF ipsilateral + TF contralateral). DE was measured in mm.
Baseline characteristics of participants were collected, including age, gender,
comorbidities, respiratory rate (RR), basal SpO2 (Oxygen saturation measured by pulse
oximeter), respiratory symptoms, and ARISCAT scale . also data were collect during
perioperative, related to BPBAC (loco-regional technique, local anesthetic, concentration,
volume of injection); related to intraoperative management (hypnotics, morphic and blocking
neuromuscular agents used); and related to postoperative (Train-Of-Four(TOF) scale, visual
analog scale (VAS) Pain, RR, SpO2, fraction of inspired oxygen (FiO2), SpO2/FiO2, existence
of postoperative pulmonary complications (PPC) ). PPC is defined as the occurrence of
dyspnea, tachypnea (RR >20% of preoperative RR), SpO2 <90%, or SpO2/FiO2 <315.
Statistical Analyses Continuous variables will be reported as medians with their
interquartile range [IQR] or means with standard deviations (SD) where applicable, and
categorical variables as counts and percentages. Group comparisons of continuous variables
will be made using the Student t-test or Mann-Whitney U test, or Wilcoxon rank-sum test as
appropriate. Chi-square test, Fisher exact test, and Kruskal-Wallis test will be used where
appropriate for categorical variables. Analyses will be performed using IBM SPSS Statistics
for Windows, Version 24.0 (IBM Corp, Armonk, NY).
SAMPLE SIZE
The sample size was calculated using Gpower 3.1. An effect size of 0.48 was calculated based
on the difference between two dependent means (matched pairs) obtained on previous pilot
study data. The occurrence of TFcontralateral variation before and after BPBAC was 12±30. A
sample size of 59 patients was required to detect a 20% of TFcontralateral variation with 95%
power and a two-sided alpha of 0.05. an increase of 10% on sample size was applied.
TOTAL n= 65 patients.
