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

NCT03600272 | Unknown

• 1 other identifier: TJ-C20180711
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor Long; Labor Pain; Labor Fetal Anoxia

Keywords

Combined spinal-epidural analgesia; Epidural analgesia; Labor duration

Outcome Measures

Primary Outcomes (1)

• Labor duration

  Duration of three stages of labor

  At the end of delivery

Secondary Outcomes (4)

• The mode of delivery

  At the end of delivery

• 1 minute and 5 minutes Apgar scores

  1 min after delivery, 5 min after delivery.

• Visual Analogue Scores(VAS)

  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.

• Modified Bromage scores

  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.

Study Arms (2)

Combined spinal-epidural analgesia

EXPERIMENTAL

The combined spinal epidural analgesia technique was used to maintain analgesia for parturients in the combined spinal-epidural analgesia group. First, the investigator injected a dose of 5 ug sufentanil into cerebrospinal fluid. If no adverse effects were observed 10 minutes after the first dose, the parturient then received mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate through a patient-controlled epidural analgesia (PCA) pump, which provided patients themixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.

Procedure: Combined spinal-epidural analgesia

Epidural analgesia

OTHER

The epidural analgesia technique was used to maintain analgesia for parturients in the epidural analgesia group, which involved placing a thin catheter through a needle inserted into the epidural space. First, the investigator injected a test dose of 5ml 1% lidocaine through it. If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.

Procedure: Epidural analgesia

Interventions

Combined spinal-epidural analgesia PROCEDURE

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.

Combined spinal-epidural analgesia

Epidural analgesia PROCEDURE

Epidural analgesia is a well-accepted technique using for pain relief during labor.

Epidural analgesia

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deng Dongrui: lead
• Tongji Hospital: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Haiyi Liu, M.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongji Han, M.D.

CONTACT

+8618971583899; handongjihospital@163.com

Xun Gong, M.D.

CONTACT

+8613886174675; gongxun4019@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One anesthetist who were not involved with clinical care or data collection performed the randomization procedure and the neuraxial block according to the group allocation. The other anesthetist blinds to the procedure preform the analgesia management after neuraxial block. This anesthetist and the obstetrician, the midwives, the patients , the outcomes collector and assessor are all blind to group allocation throughout.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief doctor

Model Details: Participants who request neuraxial labor analgesia are randomly assigned into two groups by a computer-generated random number table using Excel. One group received combined spinal-epidural analgesia during labor, the other group received epidural analgesia during labor.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 26, 2018
• Study Start: July 20, 2018
• Primary Completion: November 20, 2018
• Study Completion: July 20, 2019
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

CN (1)