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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05594771
Enrollment
276
Registered
2022-10-26
Start date
2022-11-15
Completion date
2023-08-30
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

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

the loading dose for labor analgesia administrated via epidural catheter

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
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), 5\. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.

Design outcomes

Primary

MeasureTime frameDescription
The time to onset of labor analgesia8 monthsCompare time of onset of labor analgesia and adequate analgesia was defined as VAS score\<10mm in the presence of contraction.

Secondary

MeasureTime frameDescription
VSA scores8 monthsthe Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
number of PCEA bolus requests8 monthsthe numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
analgesia drug ( ropivacaine) requests8 monthsThe total ropivacaine dose is recorded and is divided by the hours.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026