Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia

NCT04728048 | Recruiting

• 1 other identifier: 2021-2334
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized controlled study is to compare the number of physician top-up interventions during the first stage of labour between two different neuraxial analgesia techniques : the dural puncture epidural and the standard epidural.

Conditions

Obstetric Pain; Labor Pain; Anesthesia

Keywords

Dural puncture epidural; Epidural; Low dose bupivacaine

Outcome Measures

Primary Outcomes (1)

• Need for 1 physician epidural top-up

  The number of parturients who need at least one physician top-up intervention during the first stage of labour.

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

Secondary Outcomes (11)

• Number of physician epidural top-ups

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

• Timing of physician top-ups

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

• Analgesia scores

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

• Sacral block

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

• Asymetrical block

  Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

Study Arms (2)

Dural puncture epidural (group DPE)

EXPERIMENTAL

The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique. In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA). In group DPE, a single dural puncture with confirmation of free-flow CSF will be performed. If there is no free-flow CSF return through the spinal needle, the epidural catheter will be threaded 4-5cm in the epidural space and the patient will still be assigned to the DPE group, as per "intent-to-treat" protocol.

Procedure: Dural puncture epidural

Standard epidural (group EPL)

ACTIVE COMPARATOR

The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique. In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA).In Group EPL, no dural puncture will be performed and the catheter will be threaded 4-5cm in the epidural space.

Procedure: Standard epidural

Interventions

Dural puncture epidural PROCEDURE

already described

Dural puncture epidural (group DPE)

Standard epidural PROCEDURE

already described

Standard epidural (group EPL)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
• Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
• Women 18 years old and older.
• Administration of epidural analgesia between 7am and 4pm on weekdays.
• Singleton and vertex presentation foetus.
• Cervical dilatation ≤ 5 cm.
• BMI ≤ 40.
• French speaking

You may not qualify if:

• Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
• Contraindications to neuraxial analgesia: thrombocytopenia \< 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
• Known important fetal anomalies.
• Allergy to any of the medications used in the study.
• Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
• Difficulty understanding and speaking French.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Île de Montréal

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Loubert

CONTACT

5145677340; christian.loubert@umontreal.ca

Nadia Godin

CONTACT

514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 28, 2021
• Study Start: January 19, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)