Clinical trial NCT04754282: Cross-legged Versus Traditional Sitting Position for the Success of Epidural Analgesia During Labor
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
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Analgesia for Labour and Delivery
Keywords: Epidural anesthesia
Sitting position
Cross-legged position
Labour
Pain
Obstetric
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 457
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Epidural analgesia success rate
timeFrame: 20 minutes
Secondary outcomes:
measure: Patient's comfort
timeFrame: 20 minutes
measure: Patient's pain
timeFrame: 20 minutes
measure: Epidural analgesia success rate in obese patients
timeFrame: 20 minutes
measure: Successful rate of epidural analgesia catheter placement by residents
timeFrame: 20 minutes
measure: Operator satisfaction
timeFrame: 20 minutes
measure: Adverse event occurrence rate
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hawa KEITA-MEYER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Kevin SEREY, MD
role: STUDY_DIRECTOR
References:
citation: 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.