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Completed

NCT Number: NCT05594771

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural needle

Procedure

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

epidural catheter

Procedure

the loading dose for labor analgesia administrated via epidural catheter

Primary outcomes

  1. The time to onset of labor analgesia

    Time frame: 8 months

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

Secondary outcomes

  1. VSA scores

    Time frame: 8 months

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

  2. number of PCEA bolus requests

    Time frame: 8 months

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

  3. analgesia drug ( ropivacaine) requests

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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