Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl

Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor Clinical Trial

Official title:

A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395600
• Other study ID #: TWang20171226
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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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Related Conditions & MeSH terms

• Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor

Intervention

Drug:
• B1S5
Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
• B125S5
Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected
• B1S10
Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected

Locations

Country	Name	City	State
China	Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to achieve effective analgesia	We defined the onset of analgesia as the time from the start of the injection to the time when the NPRS score was reduced to at least half of the original score.	30 min
Secondary	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)		30min
Secondary	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.		delivery 24h