Clinical trial NCT03395600: Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl
Official title: A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the effects of three commonly used combination doses on the onset time and adverse reactions.

Detailed description: Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics to prolong the duration of analgesia and improve the analgesic effect. However, dose combinations of local anesthetics and opioids, especially in the initial loading dose, vary greatly from hospital to hospital and often depend upon the different routines adopted by anesthesiologists. In clinical practice, there are still some controversy about opioid dose selection in terms of analgesic onset time and adverse reactions.

In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in the clinic, and extended the observation period to 24 hours after delivery. We hypothesized that increasing the concentration of local anesthetic, rather than increasing the dose of sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the mother and fetus. To test our hypothesis, our primary outcome was to compare the times of analgesia onset of the three combinations, and the secondary outcomes were to compare the effects on maternal and infant adverse reactions.

Eligibility criteria: Inclusion Criteria:patients ASA physical status 1 or 2; early labour (cervical dilation 5 cm or less); singleton fetus; gestational age \> 36 weeks; and normal fetal heart rate (FHR) tracing. -

Exclusion Criteria:severe preeclampsia;antepartum haemorrhage; ASA 3 or more; chronic pain; substance abuse;contraindications to epidural analgesia; allergies to local anaesthetics or fentanyl; body mass index (BMI) over 40; and previous administration of opioid analgesia within 24 h.

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Primary outcomes:
measure: the time to achieve effective analgesia
timeFrame: 30 min
Secondary outcomes:
measure: Sensory block, maternal side effects (pruritus, hypotension, sedation，motor block and decreased fetal heart rate) were recorded at 5-min intervals for 30 min. sedation)
timeFrame: 30min
measure: time from the first PCA bolus, patient satisfaction, type of delivery, fever, establishment of breast feeding and LATCH score within 24 h, cumulative dosage of sufentanil/bupivacaine, time from bolus to delivery.
timeFrame: delivery 24h
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Study officials:
affiliation: Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University
name: Shaoqiang Huang, PhD
role: STUDY_CHAIR
References: