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Clinical Trials/NCT05594771
NCT05594771
Completed
Not Applicable

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

Women's Hospital School Of Medicine Zhejiang University1 site in 1 country276 target enrollmentNovember 15, 2022
ConditionsLabor Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Enrollment
276
Locations
1
Primary Endpoint
The time to onset of labor analgesia
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
August 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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,
  • 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.

Outcomes

Primary Outcomes

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

  • VSA scores(8 months)
  • number of PCEA bolus requests(8 months)
  • analgesia drug ( ropivacaine) requests(8 months)

Study Sites (1)

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