- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03366935
Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia
Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Shanghai, China
- Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women requeste labor analgesia
- ASA I or II
- at 37-42 weeks' gestation
- nulliparous
- singleton pregnancy, vertex presentation
- visual Numerical Rating Scale (VNRS) at requesting analgesia > 5 (NRPS 0-10)
- cervical dilatation < 5 cm
Exclusion Criteria:
- patient refusal to participate in the study
- age <20 years or >40 years
- body mass Index(BMI)>50 (Kg/m2)
- clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes)
- contraindications to neuraxial analgesia
- drug abuse
- conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EPL and CEI
Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
|
Procedure: Standard epidural placement(EPL) Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA). |
Active Comparator: DPE and CEI
Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
|
Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space. Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA). |
Active Comparator: DPE and PIEB
Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)
|
Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space. Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL Device: Infusion pump Infusion pump set to programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare time of onset of labor analgesia among the study groups
Time Frame: From epidural infusion initiate to delivery
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Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale
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From epidural infusion initiate to delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of side effect
Time Frame: 24 hours post delivery
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maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
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24 hours post delivery
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Sensory block level
Time Frame: 24 hours post delivery
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Sensory block will be assessed bilaterally
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24 hours post delivery
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Total anesthetic dose required
Time Frame: From epidural infusion initiate to 1h post delivery
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Including physician interventions, programmed doses, and patient controlled doses
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From epidural infusion initiate to 1h post delivery
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Mode of delivery
Time Frame: From epidural infusion initiate to delivery
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Spontaneous, Instrumental, or cesarean delivery
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From epidural infusion initiate to delivery
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Apgar scores
Time Frame: 30 mins post delivery
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The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained.
The resulting Apgar score ranges from zero to 10.
The five criteria are skin color, pulse rate, reflex irritability grimace, activity and respiratoty effort
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30 mins post delivery
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Collaborators and Investigators
Investigators
- Study Chair: YuJie Song, MD, Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Publications and helpful links
General Publications
- McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.
- Norris MC, Fogel ST, Conway-Long C. Combined spinal-epidural versus epidural labor analgesia. Anesthesiology. 2001 Oct;95(4):913-20. doi: 10.1097/00000542-200110000-00020.
- Eappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.
- Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg. 2016 Oct;123(4):965-71. doi: 10.1213/ANE.0000000000001407.
- Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
- Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
- Groden J, Gonzalez-Fiol A, Aaronson J, Sachs A, Smiley R. Catheter failure rates and time course with epidural versus combined spinal-epidural analgesia in labor. Int J Obstet Anesth. 2016 May;26:4-7. doi: 10.1016/j.ijoa.2016.01.004. Epub 2016 Jan 14.
- Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.
- Wilson SH, Wolf BJ, Bingham K, Scotland QS, Fox JM, Woltz EM, Hebbar L. Labor Analgesia Onset With Dural Puncture Epidural Versus Traditional Epidural Using a 26-Gauge Whitacre Needle and 0.125% Bupivacaine Bolus: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):545-551. doi: 10.1213/ANE.0000000000002129.
- Patkar CS, Vora K, Patel H, Shah V, Modi MP, Parikh G. A comparison of continuous infusion and intermittent bolus administration of 0.1% ropivacaine with 0.0002% fentanyl for epidural labor analgesia. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):234-8. doi: 10.4103/0970-9185.155155.
- Fettes PD, Moore CS, Whiteside JB, McLeod GA, Wildsmith JA. Intermittent vs continuous administration of epidural ropivacaine with fentanyl for analgesia during labour. Br J Anaesth. 2006 Sep;97(3):359-64. doi: 10.1093/bja/ael157. Epub 2006 Jul 18.
- Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- anesthesia dapartment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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