Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia
NCT ID: NCT03366935
Last Updated: 2018-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2017-10-10
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EPL and CEI
Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
EPL and CEI
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).
DPE and CEI
Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
DPE and CEI
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).
DPE and PIEB
Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)
DPE and PIEB
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).
Interventions
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EPL and CEI
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).
DPE and CEI
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).
DPE and PIEB
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).
Eligibility Criteria
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Inclusion Criteria
2. ASA I or II
3. at 37-42 weeks' gestation
4. nulliparous
5. singleton pregnancy, vertex presentation
6. visual Numerical Rating Scale (VNRS) at requesting analgesia \> 5 (NRPS 0-10)
7. cervical dilatation \< 5 cm
Exclusion Criteria
2. age \<20 years or \>40 years
3. body mass Index(BMI)\>50 (Kg/m2)
4. clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes)
5. contraindications to neuraxial analgesia
6. drug abuse
7. conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies
20 Years
40 Years
FEMALE
Yes
Sponsors
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Shanghai First Maternity and Infant Hospital
OTHER
Responsible Party
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Principal Investigators
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YuJie Song, MD
Role: STUDY_CHAIR
Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Locations
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Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Shanghai, , China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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anesthesia dapartment
Identifier Type: -
Identifier Source: org_study_id
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