NCT04754282

Brief Summary

The success of an epidural analgesia catheter placement depends on the parturient position. A poor posture can increase the number of punctures, patient discomfort, and risk of complications. An adequate position reverses lumbar lordosis, facilitating the access to the intervertebral space. In most cases, insertion of the epidural analgesia catheter is performed in sitting position or in lateral decubitus, the choice being generally guided by the preference of the anesthetist. According to anesthetists' experience in the obstetrical anesthesia unit at Necker-Enfants Malades hospital, a cross-legged sitting position is comfortable for parturients, restricts interfering movements during the procedure, and provides adequate widening of interspinous spaces. This position results in knees and hips flexion, tilting the pelvis backward and opening the interspinous spaces, while limiting muscular strain to maintain the position. However, literature on this matter is scarce. The aim of this study is to prove the superiority of the cross-legged position for successful placement of the epidural analgesia catheter at the first puncture without needle reorientation compared to a traditional sitting position on the edge of the bed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2022

Completed
Last Updated

March 6, 2026

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

February 10, 2021

Last Update Submit

March 4, 2026

Conditions

Keywords

Epidural anesthesiaSitting positionCross-legged positionLabourPainObstetric

Outcome Measures

Primary Outcomes (1)

  • Epidural analgesia success rate

    Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation

    20 minutes

Secondary Outcomes (6)

  • Patient's comfort

    20 minutes

  • Patient's pain

    20 minutes

  • Epidural analgesia success rate in obese patients

    20 minutes

  • Successful rate of epidural analgesia catheter placement by residents

    20 minutes

  • Operator satisfaction

    20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Traditional sitting position

ACTIVE COMPARATOR

Expecting women are positioned in a traditional sitting position for epidural analgesia catheter placement during labour.

Other: Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)

Cross-legged sitting position

EXPERIMENTAL

Expecting women are positioned in a crosse-legged sitting position for epidural analgesia catheter placement during labour.

Other: Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)

Interventions

Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days. Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh. The epidural catheter will be placed according to standard local practice in either of the groups.

Also known as: Cross-legged Sitting Position (CSP)
Cross-legged sitting position

Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days. Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called "tailor" position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh. The epidural catheter will be placed according to standard local practice in either of the groups.

Also known as: Traditional Sitting Position (TSP)
Traditional sitting position

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult women admitted to the delivery room and requesting an epidural analgesia during labour
  • Written informed consent
  • French speaking patient

You may not qualify if:

  • Patient with a contraindication to neuraxial analgesia
  • Impossibility for the patient to seat in a cross-legged position
  • No health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • Serey K, Osse L, Repesse X, Babou J, Banna L, Ayoub M, Elseblani R, Brebion M, Keita H. Cross-legged position versus traditional sitting position for epidural catheter insertion for labor analgesia: a non-randomized prospective study. Int J Obstet Anesth. 2024 Feb;57:103938. doi: 10.1016/j.ijoa.2023.103938. Epub 2023 Oct 11. No abstract available.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hawa KEITA-MEYER, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Kevin SEREY, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

February 24, 2021

Primary Completion

March 26, 2022

Study Completion

March 26, 2022

Last Updated

March 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations