Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia

• ClinicalTrials.gov Identifier: NCT03366935
• Recruitment Status: Completed
• First Posted: December 8, 2017
• Last Update Posted: August 1, 2018
• Sponsor: Shanghai First Maternity and Infant Hospital
• Information provided by (Responsible Party): Shanghai First Maternity and Infant Hospital

Study Description

Brief Summary:

This study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique and Programmed intermittent epidural bolus (PIEB) for labor analgesia.

Condition or disease	Intervention/treatment	Phase
Labor Pain; Labor Analgesia	Other: EPL and CEI; Other: DPE and CEI; Other: DPE and PIEB	Not Applicable

Detailed Description:

Epidural (EPL) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. The combined spinal epidural (CSE) technique can provide rapid onset of analgesia, but is associated with greater side effects, including pruritus, fetal bradycardia and delayed testing of epidural catheters. Dural puncture epidural (DPE) technique is a modification of CSE technique. A spinal needle is introduced through the epidural needle to create a single dural puncture , after intrathecal space was identified by the free flow of cerebrospinal fluid (CSF) , the needle was removed without direct medication administration into the subarachnoid space. Privous studies have demonstrated that the DPE technique can improve block quality over the EPL technique with fewer maternal and fetal side effects than the CSE technique for parturients requesting labor analgesia. Besides the neuraxial techniques, maintenance regimens is another factor that affect the analgesic effect. Programmed intermittent epidural bolus (PIEB) provides greater spread of local anesthetic solution within the epidural space and therefore superior quality of analgesia compared with continuous epidural infusion (CEI). We designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of DPE technique and PIEB for labor analgesia.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia
• Actual Study Start Date: October 10, 2017
• Actual Primary Completion Date: June 8, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: EPL and CEI; Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)	Other: 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).
Active Comparator: DPE and CEI; Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)	Other: 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).
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)	Other: 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).

Outcome Measures

Primary Outcome Measures :

1. Compare time of onset of labor analgesia among the study groups [ Time Frame: From epidural infusion initiate to delivery ]
   Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale

Secondary Outcome Measures :

1. Incidence of side effect [ Time Frame: 24 hours post delivery ]
   maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
2. Sensory block level [ Time Frame: 24 hours post delivery ]
   Sensory block will be assessed bilaterally
3. Total anesthetic dose required [ Time Frame: From epidural infusion initiate to 1h post delivery ]
   Including physician interventions, programmed doses, and patient controlled doses
4. Mode of delivery [ Time Frame: From epidural infusion initiate to delivery ]
   Spontaneous, Instrumental, or cesarean delivery
5. Apgar scores [ Time Frame: 30 mins post delivery ]
   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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant patients
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. women requeste labor analgesia
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:

1. patient refusal to participate in the study
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

Contacts and Locations

Locations

China

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

Shanghai, China

Sponsors and Collaborators

Shanghai First Maternity and Infant Hospital

Investigators

• Study Chair: YuJie Song, MD; Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

More Information

Publications:

Norris MC, Fogel ST, Conway-Long C. Combined spinal-epidural versus epidural labor analgesia. Anesthesiology. 2001 Oct;95(4):913-20.

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.

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.

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. Review.

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. Epub 2006 Jul 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Shanghai First Maternity and Infant Hospital
• ClinicalTrials.gov Identifier: NCT03366935
• Other Study ID Numbers: anesthesia dapartment
• First Posted: December 8, 2017
• Last Update Posted: August 1, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai First Maternity and Infant Hospital:

labor analgesia; dural puncture epidural (DPE); standard Epidural (EPL); continuous epidural infusion (CEI); programmed intermittent epidural bolus (PIEB)

Additional relevant MeSH terms:

Labor Pain; Neurologic Manifestations; Pain