Cross-legged Versus Traditional Sitting Position for the Success of Epidural Analgesia During Labor (IP3)

Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor

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.

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia for Labour and Delivery
• Intervention / Treatment: Other: Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP); Other: Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)

Detailed Description

Labour pain is one of the most intense pain known. To relieve this pain, epidural analgesia is both the most effective and the safest technique. An epidural analgesia catheter also allows for anesthesia in the event of the need for instrumental extraction or emergency caesarean section; it is thus recommended by learned societies.

The 2016 national perinatal survey conducted by the National Institute of Health and Medical Research (INSERM) and the Directorate of Research, Studies, Evaluation and Statistics (DREES) in France revealed that more than 80% of women had chosen to benefit from an epidural analgesia during labour. The first puncture failure rate ranges from 3% to almost 40% depending on the study. Identified factors for difficult epidural analgesia catheter placement were: non-palpable spinous processes, obesity, spine deformity, inability for the patient to maintain an adequate position and poor experience of the operator.

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. Different positions have been described: the lateral decubitus, the traditional sitting position, and its variants such as the squatting position, the "hamstring stretch" position, the "pendant position" (with a bilateral axillary support) and more recently the cross-legged position. 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.

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional sitting position; 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); 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.; Other Names: Traditional Sitting Position (TSP)
Experimental: Cross-legged sitting position; 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); 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.; Other Names: Cross-legged Sitting Position (CSP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural analgesia success rate	Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's comfort	Visual Analog Scale (VAS) comfort score (0 (maximum discomfort) to 10 (maximum comfort)) of parturients during the epidural analgesia catheter placement	20 minutes
Patient's pain	VAS pain score (0 (no pain) to 10 (worst imaginable pain)) of parturients during the epidural analgesia catheter placement	20 minutes
Epidural analgesia success rate in obese patients	Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation in the subpopulation of obese patients	20 minutes
Successful rate of epidural analgesia catheter placement by residents	Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation for epidurals placed by anaesthetist residents	20 minutes
Operator satisfaction	VAS satisfaction score (0 (maximum dissatisfaction) to 10 (maximum satisfaction)) of the operator in relation to the parturient's position during the procedure	20 minutes
Adverse event occurrence rate	Percentage of intra-vascular catheter position, dura-mater puncture, paraesthesia, hypotension after epidural analgesia initiation	20 minutes

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hawa KEITA-MEYER, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Kevin SEREY, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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. 2023 Oct 11:103938. doi: 10.1016/j.ijoa.2023.103938. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): March 26, 2022
• Study Completion (Actual): March 26, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Obstetric; Epidural anesthesia; Labour; Sitting position; Cross-legged position
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: APHP201193; 2020-A02267-32 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No