Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594771
Collaborator
(none)
200
2
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: epidural needle
  • Procedure: epidural catheter
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: epidural needle

the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.

Procedure: epidural needle
the loading dose for labor analgesia administrated via epidural needle before the catheter insertion

Active Comparator: epidural catheter

the loading dose for labor analgesia administrated via the epidural catheter.

Procedure: epidural catheter
the loading dose for labor analgesia administrated via epidural catheter

Outcome Measures

Primary Outcome Measures

  1. The time to onset of labor analgesia [8 months]

    Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.

Secondary Outcome Measures

  1. VSA scores [8 months]

    the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .

  2. number of PCEA bolus requests [8 months]

    the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.

  3. analgesia drug ( ropivacaine) requests [8 months]

    The total ropivacaine dose is recorded and is divided by the hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. healthy, term (37-42 weeks' gestation),

  2. nulliparous women with singleton

  3. patients in active labor with a cervical dilation <5cm who planned labor analgesia

Exclusion Criteria:
  1. any contraindication to neuraxial anesthesia,

  2. body mass index>50kg/m2,

  3. 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),

  4. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Study Director: Xinzhong Chen, Women's Hospital School Of Medicine Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT05594771
Other Study ID Numbers:
  • IRB-20220306-R
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022