Labour Analgesia Clinical Trial
Official title:
Role of the Single-shot Spinal Analgesia to Control Labour Pain in Appropriately-selected Primiparous Parturients: A Prospective Study
Labor pain is the most severe pain most women will endure in their lifetimes. The most
complete and effective method of pain relief during childbirth is neuraxial labor analgesia
which provides adequate analgesia without maternal or fetal sedation. Epidural and combined
spinal-epidural (CSE) analgesia are the standard techniques performed in the developed
countries. Having an epidural catheter in place produces flexibility with labor management.
The catheter can be dosed intermittently for parturients in whom labor is prolonged, who
require surgical manipulation for vaginal delivery, or who require cesarean section for
delivery (1). However, unavailability of full-time epidural services in low-resource
countries results in minimal or no analgesia provided to laboring parturients. The
suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly
progressing labor in primiparous and multiparous women and was found that it may be a useful
alternative for painless labor in the case of limited resources for epidural analgesia
(2,3,4). However, duration of action is a limiting factor of intrathecal analgesia,
particularly for primiparous women.
A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response
relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at
about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing
the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5
mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized
that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of
analgesia. So, this dosage combination can be used at an early stage in
appropriately-selected primigravida parturients. The purpose of this study is to investigate
the safety and effectiveness of single-dose spinal analgesia to control labor pain in
properly-selected primiparous women in a tertiary referral maternity hospital
This prospective study will be conducted in El-Minia Maternity University Hospital after
obtaining approval from the hospital ethical committee and informed consent from the
participating parturients. The study will be conducted in the period from July to october
2016. Candidates for spinal analgesia included primigravida parturients with ASA physical
status I and II, term pregnancy of singleton fetus, all vertex presentation and
uncomplicated pregnancies. Excluded from the study were patients with contraindications to
regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous
systemic opioid administration. After the parturients being in active labor, dilated at
least 4 to 5 cm and asking for painless labor, they were selected by an experienced
obstetrician to receive spinal analgesia, based on obstetric parameters such as cervical
dilatation and effacement and position of the fetal head.
Following monitoring with noninvasive blood pressure, electrocardiogram and pulse oximeter
and recording of baseline vital signs, 18-G intravenous cannula was inserted and Ringer's
solution 10 ml/kg was administered. Under strict aseptic technique, spinal analgesia was
performed using pencil-point 25G spinal needle at the L3-L4 or L4-L5 interspace with the
patients in the sitting position. The intrathecal medication included 1ml of 0.5% heavy
bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the
parturients were 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 was applied using nasal cannula (2-4 L/min). Routine monitoring included
maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram
was recorded continuously throughout the study period
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03065569 -
A Comparison of Epidural Techniques for Labour Analgesia
|
N/A |