Labor AnalgesiaNCT02873091
Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
A study testing Epidural analgesia, Continuous epidural infusion and Intermittent epidural bolus in people with Labor Analgesia, run by Nanjing Maternity and Child Health Care Hospital at 1 site in China.
Trial summary
Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- Epidural analgesia, Continuous epidural infusion and Intermittent epidural bolus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who agree to join this study
- Age: 22y-40y
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Gestation : 37-41 weeks
- Primipara
- Singleton fetus and head presentation
- In early labor: cervical dilation for 1-3cm
- Requesting labor epidural analgesia
Who cannot join
- Contraindication for epidural analgesia
- Height less than 150 cm or more than 170 cm
- Morbid obesity (BMI more than 35)
- High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
- Received parenteral opioids
- Unable to perform motor block evaluation tests
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210004
Shanwu Feng, MD, shanwufeng@163.com
About this study
Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.
- Conditions
- Labor Analgesia
- Being tested
- Epidural analgesia, Continuous epidural infusion, Intermittent epidural bolus, ropivacaine, sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaProcedure or surgery
Continuous epidural infusionProcedure or surgery
Intermittent epidural bolusProcedure or surgery
ropivacaineDrug
sufentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| CEI | Active comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose Receives: Procedure: Epidural analgesia; Procedure: Continuous epidural infusion; Drug: ropivacaine; Drug: sufentanil |
| PIEB 1 | Active comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose Receives: Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus; Drug: ropivacaine; Drug: sufentanil |
| PIEB 2 | Active comparator | Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose Receives: Procedure: Epidural analgesia; Procedure: Intermittent epidural bolus; Drug: ropivacaine; Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal visual analogue scale (VAS)
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"
Measured: At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)
Secondary outcomes (17)
Maternal modified Bromage scale
Measured: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Subject's Satisfaction with labor epidural analgesia
Measured: At the time after childbirth
Total ropivacaine and sufentanil consumption
Measured: At two hours postpartum
Proportion of parturients requiring additional PCEA boluses
Measured: At two hours postpartum
Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale
Measured: At two hours postpartum
Maternal heart rate
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Rates of cesarean delivery and instrument-assisted delivery
Measured: At time of placental delivery
Duration of analgesia
Measured: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages
Measured: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Use of oxytocin after analgesia
Measured: At twenty-four hours postpartum
Incidence of maternal side effects
Measured: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Apgar scale
Measured: At the first and fifth minutes after baby was born
Fetal heart rate
Measured: From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight
Measured: At delivery
Mean number of PCEA
Measured: At two hours postpartum
Maternal respiratory rate
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal blood pressure
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Maternity and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caijuan Li, Nanjing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873091
- Sponsor's protocol ID
- NJFY2016002
- Status last verified
- Dec 2016
- First submitted
- 11 Aug 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
- ClinicalTrials.gov ID
- NCT02873091
- Acronym / sponsor ID
- NJFY2016002
- Conditions
- Labor Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Nanjing Maternity and Child Health Care HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CEI | Active comparator | Procedure: Epidural analgesia, Procedure: Continuous epidural infusion, Drug: ropivacaine, Drug: sufentanilInitial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose |
| PIEB 1 | Active comparator | Procedure: Epidural analgesia, Procedure: Intermittent epidural bolus, Drug: ropivacaine, Drug: sufentanilInitial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose |
| PIEB 2 | Active comparator | Procedure: Epidural analgesia, Procedure: Intermittent epidural bolus, Drug: ropivacaine, Drug: sufentanilInitial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects who agree to join this study
- Age: 22y-40y
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Gestation : 37-41 weeks
- Primipara
Key exclusion criteria (6 listed)
- Contraindication for epidural analgesia
- Height less than 150 cm or more than 170 cm
- Morbid obesity (BMI more than 35)
- High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
- Received parenteral opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesia | Procedure or surgery | CEI, PIEB 1, PIEB 2 |
| Continuous epidural infusion | Procedure or surgery | CEI |
| Intermittent epidural bolus | Procedure or surgery | PIEB 1, PIEB 2 |
| ropivacaine | Drug | CEI, PIEB 1, PIEB 2 |
| sufentanil | Drug | CEI, PIEB 1, PIEB 2 |
Primary outcome
Maternal visual analogue scale (VAS)
Time frame: At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"
17 secondary outcomes
Maternal modified Bromage scale
Time frame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Subject's Satisfaction with labor epidural analgesia
Time frame: At the time after childbirth
Total ropivacaine and sufentanil consumption
Time frame: At two hours postpartum
Proportion of parturients requiring additional PCEA boluses
Time frame: At two hours postpartum
Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale
Time frame: At two hours postpartum
Maternal heart rate
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Rates of cesarean delivery and instrument-assisted delivery
Time frame: At time of placental delivery
Duration of analgesia
Time frame: Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages
Time frame: From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Use of oxytocin after analgesia
Time frame: At twenty-four hours postpartum
Incidence of maternal side effects
Time frame: Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Apgar scale
Time frame: At the first and fifth minutes after baby was born
Fetal heart rate
Time frame: From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight
Time frame: At delivery
Mean number of PCEA
Time frame: At two hours postpartum
Maternal respiratory rate
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal blood pressure
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia, Continuous epidural infusion and Intermittent epidural bolus in people with Labor Analgesia, run by Nanjing Maternity and Child Health Care Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caijuan Li, M.A. (025-52226112, licaijuanyumi1228@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal visual analogue scale (VAS) (time frame: At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.