Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03098420 |
| Other study ID # |
F160421006 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
May 20, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study aims to improve the care of the obstetric population after cesarean section and
improve total patient satisfaction by improving post-surgical pain control with the use of
dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a
dose-escalation of dexamethasone in the TAP block to observe its effects at specific small
doses. It is the hope of the investigator that the studied technique would become utilized
routinely for the obstetric population following cesarean section.
The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks
will prolong the duration of the block in a dose-dependent fashion. The investigators hope to
improve post-operative pain following cesarean section, increase duration of TAP block with
use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease
opioid requirements after cesarean section.
The primary endpoint will be estimation of duration of TAP block, being assessed within 48
hours after surgery. Secondary endpoints will include pain scores both in PACU and on the
floor, average pain scores, time until first opioid administration, total opioid consumption
in first 48 hours, use of PONV medications, and overall patient satisfaction.
Description:
Preoperatively: informed consent will be obtained by a member of this study. The patients
will be screened for inclusion/exclusion criteria on day of procedure, and then the
participants will be randomized to one of three groups.
Intraoperatively: The anesthesia team involved with care of patient in the operating room
will provide routine anesthesia care during the cesarean section including neuraxial
anesthesia with intrathecal bupivacaine and morphine.
After completion of the procedure, the patients will receive bilateral TAP block procedure
while still in OR. All blocks will include 20mL of 0.5% ropivacaine, and the patients will be
randomly assigned a specific dose of dexamethasone at 0mg (given normal saline as control),
2mg, or 4mg. The resident or attending physician supervising the block will be investigators
of the study, and they along with the residents performing the blocks will be blinded to the
amount of dexamethasone in the injectate.
Postoperatively: The patients will then be monitored in the PACU for approximately 30-60
minutes and then subsequently monitored on an inpatient floor. Pain scores, time until first
opioid dose, total opioid requirement will be assessed and recorded. In PACU, these will be
recorded every 15-30 minutes. On the inpatient floor, these will be recorded every 6 hours.
Pain scores, average pain scores in first 48 hours, total opioid consumption, time until
first opioid use, and PONV medication requirement will also be recorded. These will be
recorded by review of the electronic medical record.
Satisfaction scores and estimation of TAP block duration will be assessed and recorded by
anesthesia personnel approximately 48 hours post-operatively; these will be subjective
evaluations recorded between 24-38 hours postoperatively. The patients will be asked to
estimate how long they felt the block lasted. For satisfaction scores, patients will rate
their satisfaction subjectively on a scale of 1-10.
Statistical Analysis: all demographic and clinical variables with continuous measures will be
expressed as means and standard deviations; categorical factors will be expressed as
proportions. For non-normal data, the medians and inter quartile ranges will be displayed.
The distribution of the continuous factors will be examined using the Kolmogorov-Smirnov
test. For data that are normally distributed, one-way ANOVA will be used to compare groups of
data. For data that are not normally distributed, the Kruskal-Wallis test will be used for
comparisons. Chi-square and Fisher's exact tests will be used to analyze categorical data.
For all comparisons, a value of p < 0.05 will be considered statistically significant.
Statistical analyses will be performed using SAS for Windows, version 9.2. One-way ANOVA (or
the Kruskal-Wallis test, as appropriate) will be used to compare duration of TAP block for
the three groups. Linear regression will also be used to test the relationship between
duration of block and dexamethasone dose, while controlling for relevant clinical and
demographic variables.
One-way ANOVA (or the Kruskal-Wallis test) will be used to compare the groups on
post-operative pain scores, opioid requirements, and patient satisfaction scores.
Statistical Power and Sample Size Estimates: Approximately 69 subjects (23 per group) are
expected to be enrolled in this study. Given this sample size and assuming that the average
duration of TAP block is 18 hours for the control group, 22 hours for the 2 mg of
dexamethasone group, and 24 hours for the 4 mg of dexamethasone group, this study will have
approximately 80.9% power to detect a difference in block duration, assuming a common
standard deviation of 6 hours. If the variability in block time is smaller than 6 hours, this
study will have greater power.
