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

NCT05594771 | Completed

• 1 other identifier: IRB-20220306-R
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (3)

• VSA scores

  8 months

• number of PCEA bolus requests

  8 months

• analgesia drug ( ropivacaine) requests

  8 months

Study Arms (2)

epidural needle

EXPERIMENTAL

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

Procedure: epidural needle

epidural catheter

ACTIVE COMPARATOR

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

Procedure: epidural catheter

Interventions

epidural needle PROCEDURE

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

epidural needle

epidural catheter PROCEDURE

the loading dose for labor analgesia administrated via epidural catheter

epidural catheter

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, term (37-42 weeks' gestation),
• nulliparous women with singleton
• patients in active labor with a cervical dilation \<5cm who planned labor analgesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Chen X, Tang Y, Yu Q, Sun L, Li H, Wang L, Jiao C, Chen X. Comparative study of labour analgesia onset with injection of loading dose through epidural needle versus catheter: A prospective, double-blinded, randomised clinical trial. Eur J Anaesthesiol. 2025 Feb 1;42(2):113-121. doi: 10.1097/EJA.0000000000002077. Epub 2024 Oct 16.

  PMID: 39744745 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinzhong Chen

  Women's Hospital School Of Medicine Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 26, 2022
• Study Start: November 15, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 6, 2024

Record last verified: 2022-10

Locations

CN (1)