Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06099938 |
| Other study ID # |
june617 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
First Affiliated Hospital of Jinan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: The purpose of this study was to see how intrathecal injections of sufentanil,
ropivacaine, and sufentanil added to ropivacaine affected blood flow in the uterine artery,
umbilical artery, and middle cerebral artery for combined spinal and epidural labor analgesia
using color doppler ultrasound (CDUs).
Methods: A total of 90 singleton full-term parturients who were evaluated by obstetricians
for feasible vaginal delivery were collected prospectively and divided into three groups
based on the randomization and double-blind principle: sufentanil (S), ropivacaine (R) group,
each with 30 cases. Main indicators include color doppler blood flow resistance indices (S/D)
of the uterine artery (UtA), umbilical artery (UA), and middle cerebral artery (MCA) before
(T0) and 30 minutes (T1), 60 minutes (T2), 90minutes (T3) after analgesia. Fetal heart rate
(FHR), maternal mean arterial pressure (MAP) at T0, T1, T2 and T3。
Description:
1. Randomization and blinding Parturients in the study were randomly assigned to Sufentanil
group (S) and Ropivacaine group (R) by non-blind personnel according to the computer
random number table, and the allocation was hidden. The solution was prepared by an
unblinded anesthesiologist and packaged in a blind way and administered by another
anesthesiologist. The patients, anesthesia providers, data recorders, ultrasound
examiners, obstetrical staff, and nursing staff remained blinded to group assignment
throughout the study.
2. Study intervention At the time of request for labor analgesia, patients were randomized
to receive either sufentanil 5 μg (Group S) and ropivacaine 3mg (Group R) into the
subarachnoid space. All groups received the standard epidural solution that contained
0.1% ropivacaine with 0.25 μg/ml sufentanil. Routine obstetric and anaesthetic
monitoring was given after maternal entered the delivery room. An experienced the
anesthesiologist select L3-4 lumbar vertebra clearance to puncture with standard sterile
technique using loss of resistance when the puerpera palace has expanded to about 3 cm.
After the puncture reached the epidural space, a 25-gauge lumbar anesthesia needle was
used to puncture into the subarachnoid space. 2 mL of anesthetic drug as determined by
her group randomization were administered into the cavity through the lumbar anesthesia
needle after cerebrospinal fluid flow out. A 19-gauge spring-wound catheter was threaded
4-6 cm into the epidural space. All patients received a test dose of 3 ml of 1.5%
lidocaine followed by an initial loading dose of 5 ml of the standard epidural solution.
Epidural catheters into vessels or subarachnoid space were excluded. An analgesic pump
(PCEA pump, 100ml) containing standard epidural solution was then connected to the
epidural catheter at a background continuous infusion rate of 5 mL/h. The visual
analogue score for pain (VAS) was performed 15 minutes after the injection dose, and if
the VAS score fell below 3, the case was included in the study.
An anesthesia provider assessed the adequacy of analgesia for the patients throughout
the duration of labor. Any breakthrough pain was managed with a physician-administered
epidural bolus. All obstetric analgesia procedures were performed by the same
anesthesiologist to reduce errors due to technical reasons.
3. Ultrasonic examination method The patients were placed in a supine position with calm
breathing to perform doppler ultrasonography during the interval of contractions.
Ultrasound probe was placed on fetal head area. Middle cerebral arteries (MCA) run
anteriorly on both sides of the ring of cerebral arteries at the position of the double
head diameter (see Figure 1A). We can get waveforms of MCA examined by pulsed wave
doppler (see Figure 1B). The probe was placed at the placenta area, and we can see the
fetal umbilical cord connecting to the center of the placenta. Umbilical artery (UA)
could be identified by color flow, and its waveforms were examined by pulsed wave
doppler (see Figure 1C and 1D). The probe was placed at the midpoint of the groin. The
right and left uterine arteries (UtA) could be identified by color flow at the apparent
crossover with the external iliac arteries, and pulsed wave doppler was used to obtain
waveforms (see Figure 1E and 1F). 3 to 10 arterial spectrograms with clear edges and no
background noise at baseline were selected. The above arterial blood flow indexes were
measured three times and the average value was taken. The S/Dvalue of MCA、UA、UtA can be
measured automatically by ultrasound instrument. All doppler examinations were performed
by the same sonographer.
