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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Sufentanil and Ropivacaine

NCT02488291

Anesthesia Complications

COMPLETED NA

Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

NCT03622047

Pharmacological Action

UNKNOWN NA

Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia

NCT01205360

Primigravida in Labour Pains

WITHDRAWN NA

Determination of the Effective Volume of 0.125% Bupivacaine-fentanyl 5mcg/mL in Labour Epidurals

NCT01972269

Pain

COMPLETED NA

Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

NCT05698407

Pregnancy Related

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.1%bupivacaine+10µg sufentanyl

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

Group Type ACTIVE_COMPARATOR

B1S10

Intervention Type DRUG

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

0.125%bupivacaine+5µg sufentanyl

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

Group Type ACTIVE_COMPARATOR

B125S5

Intervention Type DRUG

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

0.1%bupivacaine+5µg sufentanyl

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

Group Type ACTIVE_COMPARATOR

B1S5

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG