Comparison of Labor Analgesia Between Modified Combined Spinal-Epidural and Dural Puncture Epidural Techniques

NCT03258879 | Unknown

• 1 other identifier: 10017388
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of neuraxial anesthesia used to provide pain relief in laboring women . The investigators want to assess the onset of pain relief with 2 different neuraxial techniques performed at our center, but which have not yet been compared in the literature: (1) Modified CSE, with only local anesthetic injected into the spinal fluid to reduce side effects of opioids that are seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of the spinal membrane, but without injection of medication into the spinal space. The investigators hypothesize that the onset of labor analgesia will be faster with modified CSE compared to DPE.

Conditions

To Determine the Onset of Analgesia (Numerical Rating Scale for Pain = 1) in Minutes

Keywords

Combined spinal epidural analgesia, dural puncture epidural

Outcome Measures

Primary Outcomes (1)

• Comparison of the onset of effective analgesia between the study techniques

  Numerical Rating Scale (NRS) for pain \</= 1/10 in minutes

  1 year

Secondary Outcomes (3)

• Comparison of block quality between the study techniques

  1 year

• Comparison of the incidence of pruritus between the study techniques

  1 year

• Comparison of the incidence of fetal bradycardia between the study techniques

  1 year

Study Arms (2)

Modified CSE

EXPERIMENTAL

MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally

Procedure: Modified CSE

Dural puncture epidural

ACTIVE COMPARATOR

Dural puncture performed with a spinal needle, but no medication will be injected intrathecally.

Procedure: Dural puncture epidural

Interventions

Modified CSE PROCEDURE

MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally

Modified CSE

Dural puncture epidural PROCEDURE

DPE group: Dural puncture performed, but no medication will be injected intrathecally.

Dural puncture epidural

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II healthy adult parturients, at 37-40 weeks gestation with singleton pregnancy and vertex presentation.
• Parturients in early labor with cervical dilatation less than 6 cm requesting epidural analgesia
• Parturients able to provide written informed consent.

You may not qualify if:

• Patient refusal to participate in the study.
• Presence of clinically significant disease
• Contraindications to neuraxial analgesia.
• Presence of conditions associated with an increased risk of a cesarean delivery like history of uterine anomaly or surgery, morbid obesity and known fetal anomalies or non-reassuring fetal heart rate.

Sponsors & Collaborators

• Western University, Canada: lead

Study Officials

• Indu Singh, MD, FRCPC

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yamini Subramani, MD

CONTACT

519-902-4715; yaminisrs@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: August 23, 2017
• Study Start: January 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share