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

Epidural Analgesia for Labour and Delivery Clinical Trial

— IP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754282
• Other study ID #: APHP201193
• Secondary ID: 2020-A02267-32
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: March 26, 2022

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural Analgesia for Labour and Delivery

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural analgesia success rate	Percentage of epidural analgesia catheter placement success at first puncture without needle reorientation	20 minutes
Secondary	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
Secondary	Patient's pain	VAS pain score (0 (no pain) to 10 (worst imaginable pain)) of parturients during the epidural analgesia catheter placement	20 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse event occurrence rate	Percentage of intra-vascular catheter position, dura-mater puncture, paraesthesia, hypotension after epidural analgesia initiation	20 minutes