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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
B1S5
B125S5
B1S10
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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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Sites / Locations

  • Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0.1%bupivacaine+10µg sufentanyl

0.125%bupivacaine+5µg sufentanyl

0.1%bupivacaine+5µg sufentanyl

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.

Full Information

First Posted
January 4, 2018
Last Updated
June 5, 2019
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03395600
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1%bupivacaine+10µg sufentanyl
Arm Type
Active Comparator
Arm Description
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
Arm Title
0.125%bupivacaine+5µg sufentanyl
Arm Type
Active Comparator
Arm Description
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
Arm Title
0.1%bupivacaine+5µg sufentanyl
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
B1S5
Intervention Description
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
Intervention Name(s)
B125S5
Intervention Description
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
Intervention Name(s)
B1S10
Intervention Description
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
Primary Outcome Measure Information:
Title
the time to achieve effective analgesia
Description
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.
Time Frame
30 min
Secondary Outcome Measure Information:
Title
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)
Time Frame
30min
Title
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.
Time Frame
delivery 24h

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoqiang Huang, PhD
Organizational Affiliation
Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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