Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05271760 |
| Other study ID # |
REC-HSD-64-2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Prince Sattam Bin Abdulaziz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this prospective, randomized, and controlled trial was to compare the efficacy
of single-shot spinal analgesia to typical conventional treatments (continuous epidural
analgesia and spinal-epidural combination) in reducing labor pain, particularly in
multiparous women.
we will enroll in each of the three groups(S group= single-shot Spinal group), (E group=
Continuous Epidural), and (C group = combined spinal-epidural) women in advanced active labor
and fulfill inclusion criteria.
Description:
Patients in active labor with cervical dilation between 4-5 cm multiparous with normal fetal
heart rate (FHR) tracings were considered. After the request for analgesia, each patient was
randomized, using a computer-generated randomization table, to receive spinal analgesia,
continuous epidural analgesia, or combined spinal-epidural analgesia. Under A complete
aseptic condition in a sitting position, all techniques are performed in the Labor and
delivery room. All parturients are categorized into three groups as follows:
Group S (spinal n=40) The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5
mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Group E
(continuous Epidural n=40): Epidural analgesia is performed using a 16-gauge Tuohy epidural
needle using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance
an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4
epidural space, after negative aspiration for blood or spinal fluid a test dose of 3 ml
lidocaine 1.5% with epinephrine 1:200000 will be given via inserted catheter, 10 ml of 0.125
% bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will
infuse in a rate of 6 -14 ml/h.
Group C (Combined spinal-epidural n=40) Epidural analgesia is performed using a combined
spinal-epidural set. using a loss-of-resistance- to-saline technique, upon feeling the loss
of resistance, once epidural space will be detected, 27 G Whitacre spinal needle inserted
through Touhy epidural needle, intrathecal injection of 1ml of 0.5% heavy bupivacaine (5 mg)
and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Then an epidural
catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural
space, after negative aspiration for blood or spinal fluid.
10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the
solution will infuse at a rate of 6 -14 ml/h if needed.
Then, the parturients will be placed in the supine position with left lateral displacement
produced by placing a wedge under the right hip to prevent aortocaval compression and
hypotension. Supplemental oxygen will be applied using a nasal cannula (2-4 L/min).
Each patient will receive at least 10 mL/kg Ringer lactate solution. All patients will be
monitored before the procedures and every 5 minutes after for 30 for any hemodynamic
instability and fetal viability The duration of analgesia is defined as the time from the
injection of the local anesthetic solution until the patient requested an additional
analgesic dose.
After the administration of the anesthetic solution, each patient will be evaluated by an
investigator every 5 min for the first 15 min. Patients are assessed every 15 min until
additional analgesia is requested.
Patient appraisal included Assessment of vital signs (blood pressure, heart rate, respiratory
rate) and completion by the patient of a 10-cm linear visual analog scale (VAS) for pain (0=
no pain; 10 = severe pain). Patients will be excluded from the final data analysis if the
patients reported pain VAS >8 up to 15 min after the injection of the anesthetic solution. At
the same time intervals, somnolence will be evaluated using a four-point ordinal scale in
which 0= wide awake, 1= drowsy, 2= arousable, 3 = non-arousable, the Motor blockade will be
assessed using the four-point Bromage scale. The upper level of loss of sensation to ice will
be assessed in the mid-clavicular line 15 min after the injection of the anesthetic solution.
Time 2 segment regressions will be assessed. Side effects such as Pruritus, nausea, or
vomiting Patient and obstetrician satisfaction. All patients have continuous electronic FHR
monitoring throughout labor. Any FHR abnormalities, identified by the obstetric team, will be
documented. After labor, the baby will be assessed, and the mother will be nursed in a
post-anesthetic care unit (PACU ) and observed if there is nausea, vomiting, dyspnea,
hemodynamic changes (hypotension and reflex tachycardia), and Spo2 changes will be recorded
too, also patient will be evaluated for any Sensory or motor complication. The purpose of
this study is to investigate the safety and effectiveness of single-dose spinal or epidural
analgesia to control labor pain in properly-selected multiparous women in a tertiary referral
maternity hospital.
