Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Primary Purpose
Labor Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
epidural needle
epidural catheter
Sponsored by
About this trial
This is an interventional other trial for Labor Pain
Eligibility Criteria
Inclusion Criteria:
- healthy, term (37-42 weeks' gestation),
- nulliparous women with singleton
- patients in active labor with a cervical dilation <5cm who planned labor analgesia
Exclusion Criteria:
- any contraindication to neuraxial anesthesia,
- body mass index>50kg/m2,
- VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),
5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
epidural needle
epidural catheter
Arm Description
the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.
the loading dose for labor analgesia administrated via the epidural catheter.
Outcomes
Primary Outcome Measures
The time to onset of labor analgesia
Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.
Secondary Outcome Measures
VSA scores
the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
number of PCEA bolus requests
the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
analgesia drug ( ropivacaine) requests
The total ropivacaine dose is recorded and is divided by the hours.
Full Information
NCT ID
NCT05594771
First Posted
October 22, 2022
Last Updated
October 22, 2022
Sponsor
Women's Hospital School Of Medicine Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05594771
Brief Title
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Official Title
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.
Detailed Description
The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique.
In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epidural needle
Arm Type
Experimental
Arm Description
the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.
Arm Title
epidural catheter
Arm Type
Active Comparator
Arm Description
the loading dose for labor analgesia administrated via the epidural catheter.
Intervention Type
Procedure
Intervention Name(s)
epidural needle
Intervention Description
the loading dose for labor analgesia administrated via epidural needle before the catheter insertion
Intervention Type
Procedure
Intervention Name(s)
epidural catheter
Intervention Description
the loading dose for labor analgesia administrated via epidural catheter
Primary Outcome Measure Information:
Title
The time to onset of labor analgesia
Description
Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
VSA scores
Description
the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
Time Frame
8 months
Title
number of PCEA bolus requests
Description
the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
Time Frame
8 months
Title
analgesia drug ( ropivacaine) requests
Description
The total ropivacaine dose is recorded and is divided by the hours.
Time Frame
8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy, term (37-42 weeks' gestation),
nulliparous women with singleton
patients in active labor with a cervical dilation <5cm who planned labor analgesia
Exclusion Criteria:
any contraindication to neuraxial anesthesia,
body mass index>50kg/m2,
VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),
5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinzhong Chen
Phone
0571-87061501
Email
chenxinz@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Chen
Email
5513041@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinzhong Chen
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
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