A Study on the Effect of Position on Walking Labour Epidural Efficacy

Study Overview
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Brief Summary
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This study is being done to better understand how patient positioning can affect pain relief after an epidural. In addition to pain, the investigators will assess how position affects epidural spread, and its effects on maternal blood pressure and fetal heart rate.

Detailed Description
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Epidurals will be placed with parturients in the standard sitting position. An epidural catheter will be placed to a depth of 5 cm into the epidural space. After placement, parturients will be randomized to one of the four position groups (left uterine displacement, left lateral, right lateral, or seated upright). After successful positioning, a series of 5 cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through the epidural catheter in 5 minute intervals for a total volume of 20 cc. After the initial loading dose of epidural solution has been injected in the first 20 minutes post-insertion, the patient will be able to return to whatever position they are most comfortable with. The parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the peak of their contraction at three time intervals. The spread of the blockade will be assessed with ice applied along both the left and right mid-clavicular lines. Maternal blood pressure will be measured on the upper arm in all patients as per nursing protocol. Fetal heart rate will be monitored intermittently with Doppler ultrasound as per nursing protocol.

Official Title
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Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia

Conditions
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Labor Pain, Analgesia, Epidural

Intervention / Treatment
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* Procedure: Lumbar Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active labour or admitted for induction of labour Requesting an epidural for labour analgesia Contractions occurring greater than once every 5 minutes Exclusion Criteria: Coagulation disorder High risk pregnancy as per obstetrics Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Uterine Displacement<br>Supine with left tilt for uterine displacement | Procedure: Lumbar Epidural<br>* Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.<br>|
| Experimental: Left Lateral<br>Left lateral decubitus position | Procedure: Lumbar Epidural<br>* Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.<br>|
| Experimental: Right Lateral<br>Right lateral decubitus position | Procedure: Lumbar Epidural<br>* Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.<br>|
| Experimental: Upright<br>Upright seated position | Procedure: Lumbar Epidural<br>* Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labour pain based on verbal rating pain scale | Pain with contractions, assessed using a 0 to 10 verbal rating pain scale; 0 being no pain with a contraction and 10 being the worse pain with a contraction. | Taken at time 0 minutes after epidural insertion | 
| Labour pain based on verbal rating pain scale | Pain with contractions, assessed using a 0 to 10 verbal rating pain scale; 0 being no pain with a contraction and 10 being the worse pain with a contraction. | Taken at time 20 minutes after epidural insertion | 
| Labour pain based on verbal rating pain scale | Pain with contractions, assessed using a 0 to 10 verbal rating pain scale; 0 being no pain with a contraction and 10 being the worse pain with a contraction. | Taken at time 40 minutes after epidural insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of epidural levels based on dermatomes | Levels of analgesia assessed via temperature insensitivity to ice on the right and left side along the midclavicular lines of the patient and reported as dermatome levels. | Taken at time 20 minutes after epidural insertion | 
| Assessment of epidural levels based on dermatomes | Levels of analgesia assessed via temperature insensitivity to ice on the right and left side along the midclavicular lines of the patient and reported as dermatome levels. | Taken at time 40 minutes after epidural insertion | 
| Category of epidural based on bilateral dermatome levels | Epidural assessed if it is successful, unilateral (more than two dermatome level difference between sides), patchy (one or more areas between dermatomes that remain sensitive to temperature assessment), or failed (no measurable dermatome levels) based on the dermatome levels gathered by nursing assessments. | Taken at time 20 minutes after epidural insertion | 
| Category of epidural based on bilateral dermatome levels | Epidural assessed if it is successful, unilateral (more than two dermatome level difference between sides), patchy (one or more areas between dermatomes that remain sensitive to temperature assessment), or failed (no measurable dermatome levels) based on the dermatome levels gathered by nursing | Taken at time 40 minutes after epidural insertion | 
| Events of maternal hypotension after epidural placement | Hypotensive events defined as a deviation of greater than 20% of maternal blood pressure compared to pre-epidural baseline. | Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion | 
| Events of fetal bradycardia after epidural placement | Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement. | Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Obstetrical, Posture, Pregnancy, Female, Heart Rate, Fetal, Hypotension