An observational study in Labor Pain, Analgesia and Fetus Disorder, sponsored by First Affiliated Hospital of Jinan University. Completed at 1 site in China. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by First Affiliated Hospital of Jinan University · Observational
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。
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 90 is below the median of 101 across 56 observational studies indexed under Labor Pain.
Browse Labor Pain studies →First Affiliated Hospital of Jinan University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA grade I to II, aged 20 to 35 years, weighing 50 to 100 kg, 150-175 cm in height, and 37 to 41 weeks of gestation
Exclusion Criteria:
intrathecal injections of sufentanil
Drug: sufentanil, ropivacaine
intrathecal injections of ropivacaine
Drug: sufentanil, ropivacaine
The study used conventional anesthetic drugs to compare the effects of the two drugs on maternal and infant blood flow
Also known as: Color Doppler ultrasound
color doppler blood flow resistance indices (S/D)
S/D is an abbreviation for systolic/diastolic blood pressure.The patients were placed in a supine position with calm breathing to perform Doppler ultrasonography during the interval of contractions.
Time frame: S/D measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
FHR
Fetal heart rate
Time frame: Fetal heart rate measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
MAP
Mean arterial pressure
Time frame: Mean arterial pressure before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
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First Affiliated Hospital of Jinan University