Clinical trial NCT05594771: Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Official title: Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 276
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The time to onset of labor analgesia
timeFrame: 8 months
Secondary outcomes:
measure: VSA scores
timeFrame: 8 months
measure: number of PCEA bolus requests
timeFrame: 8 months
measure: analgesia drug ( ropivacaine) requests
timeFrame: 8 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Anesthesiology, Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Xinzhong Chen
role: STUDY_DIRECTOR
References: