Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395600
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Tingting Wang, Fudan University

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

Condition or disease Intervention/treatment Phase
Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor Drug: B1S5 Drug: B125S5 Drug: B1S10 Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor
Actual Study Start Date : February 10, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : October 31, 2018


Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: 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
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

Active Comparator: 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
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




Primary Outcome Measures :
  1. the time to achieve effective analgesia [ Time Frame: 30 min ]
    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 :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395600


Locations
Layout table for location information
China
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Shanghai, China
Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Study Chair: Shaoqiang Huang, PhD Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University
Layout table for additonal information
Responsible Party: Tingting Wang, , Fudan University
ClinicalTrials.gov Identifier: NCT03395600    
Other Study ID Numbers: TWang20171226
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms