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

Primary Purpose

Epidural Analgesia for Labour and Delivery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)
Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural Analgesia for Labour and Delivery focused on measuring Epidural anesthesia, Sitting position, Cross-legged position, Labour, Pain, Obstetric

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Necker-Enfants Malades

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional sitting position

Cross-legged sitting position

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient's comfort
Visual Analog Scale (VAS) comfort score (0 (maximum discomfort) to 10 (maximum comfort)) of parturients during the epidural analgesia catheter placement
Patient's pain
VAS pain score (0 (no pain) to 10 (worst imaginable pain)) of parturients during the epidural analgesia catheter placement
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
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
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
Adverse event occurrence rate
Percentage of intra-vascular catheter position, dura-mater puncture, paraesthesia, hypotension after epidural analgesia initiation

Full Information

First Posted
February 10, 2021
Last Updated
April 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04754282
Brief Title
Cross-legged Versus Traditional Sitting Position for the Success of Epidural Analgesia During Labor
Acronym
IP3
Official Title
Impact of a Cross-legged Versus Traditional Sitting Position for the Success of an Epidural Analgesia Catheter Placement During Labor
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
March 26, 2022 (Actual)
Study Completion Date
March 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural Analgesia for Labour and Delivery
Keywords
Epidural anesthesia, Sitting position, Cross-legged position, Labour, Pain, Obstetric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional sitting position
Arm Type
Active Comparator
Arm Description
Expecting women are positioned in a traditional sitting position for epidural analgesia catheter placement during labour.
Arm Title
Cross-legged sitting position
Arm Type
Experimental
Arm Description
Expecting women are positioned in a crosse-legged sitting position for epidural analgesia catheter placement during labour.
Intervention Type
Other
Intervention Name(s)
Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)
Other Intervention Name(s)
Traditional Sitting Position (TSP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)
Other Intervention Name(s)
Cross-legged Sitting Position (CSP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epidural analgesia success rate
Description
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Patient's comfort
Description
Visual Analog Scale (VAS) comfort score (0 (maximum discomfort) to 10 (maximum comfort)) of parturients during the epidural analgesia catheter placement
Time Frame
20 minutes
Title
Patient's pain
Description
VAS pain score (0 (no pain) to 10 (worst imaginable pain)) of parturients during the epidural analgesia catheter placement
Time Frame
20 minutes
Title
Epidural analgesia success rate in obese patients
Description
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation in the subpopulation of obese patients
Time Frame
20 minutes
Title
Successful rate of epidural analgesia catheter placement by residents
Description
Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation for epidurals placed by anaesthetist residents
Time Frame
20 minutes
Title
Operator satisfaction
Description
VAS satisfaction score (0 (maximum dissatisfaction) to 10 (maximum satisfaction)) of the operator in relation to the parturient's position during the procedure
Time Frame
20 minutes
Title
Adverse event occurrence rate
Description
Percentage of intra-vascular catheter position, dura-mater puncture, paraesthesia, hypotension after epidural analgesia initiation
Time Frame
20 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawa KEITA-MEYER, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin SEREY, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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