Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia for Pain Management During Labor

Labor Pain Clinical Trial

Official title:

Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia During Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03600272
• Other study ID #: TJ-C20180711
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2018
• Source: Tongji Hospital
• Contact: Dongji Han, M.D.
• Phone: +8618971583899
• Email: handongjihospital[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.

Description:

Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 20, 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.

Exclusion Criteria:

• Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications

Related Conditions & MeSH terms

• Fetal Hypoxia
• Labor Fetal Anoxia
• Labor Long
• Labor Pain

Intervention

Procedure:
• Combined spinal-epidural analgesia
Combined spinal-epidural analgesia during labor is a labor analgesia technique which reported maybe associate with a shorter labor duration compared to the traditional epidural labor analgesia.
• Epidural analgesia
Epidural analgesia is a well-accepted technique using for pain relief during labor.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Deng Dongrui	Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Labor duration	Duration of three stages of labor	At the end of delivery
Secondary	The mode of delivery	Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery	At the end of delivery
Secondary	1 minute and 5 minutes Apgar scores	Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10.	1 min after delivery, 5 min after delivery.
Secondary	Visual Analogue Scores(VAS)	VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants.	At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs; at cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.
Secondary	Modified Bromage scores	The modified Bromage score is the most frequently used measure of motor block. In this scale, the intensity of motor block is assessed by the patient's ability to move their lower extremities(0: no motor paralysis; 1: inability to raise extended leg, but able to move knee and foot; 2: inability to raise extended leg and to move knee, but able to move foot; 3: inability to raise extended leg or to move knee and foot).	At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs; at the cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.