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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Combined spinal-epidural analgesia

Epidural analgesia

About this trial

This is an interventional treatment trial for Labor Long focused on measuring Combined spinal-epidural analgesia, Epidural analgesia, Labor duration

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Combined spinal-epidural analgesia

Epidural analgesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Labor duration

Duration of three stages of labor

Secondary Outcome Measures

The mode of delivery

Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery

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.

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.

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).

Full Information

NCT ID

NCT03600272

First Posted

July 10, 2018

Last Updated

July 25, 2018

Sponsor

Deng Dongrui

Collaborators

Tongji Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03600272

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 20, 2018 (Anticipated)

Primary Completion Date

November 20, 2018 (Anticipated)

Study Completion Date

July 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Deng Dongrui

Collaborators

Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Long, Labor Pain, Labor Fetal Anoxia

Keywords

Combined spinal-epidural analgesia, Epidural analgesia, Labor duration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined spinal-epidural analgesia

Arm Type

Experimental

Arm Description

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.

Arm Title

Epidural analgesia

Arm Type

Other

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Combined spinal-epidural analgesia

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Epidural analgesia

Intervention Description

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

Primary Outcome Measure Information:

Title

Labor duration

Description

Duration of three stages of labor

Time Frame

At the end of delivery

Secondary Outcome Measure Information:

Title

The mode of delivery

Description

Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery

Time Frame

At the end of delivery

Title

1 minute and 5 minutes Apgar scores

Description

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.

Time Frame

1 min after delivery, 5 min after delivery.

Title

Visual Analogue Scores(VAS)

Description

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.

Time Frame

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.

Title

Modified Bromage scores

Description

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).

Time Frame

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dongji Han, M.D.

Phone

+8618971583899

Email

handongjihospital@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xun Gong, M.D.

Phone

+8613886174675

Email

gongxun4019@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haiyi Liu, M.D.

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dongji han, M.D.

Phone

+8618971583899

Email

handongjihospital@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Labor Long, Labor Pain, Labor Fetal Anoxia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial