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

Primary Purpose

Labor Pain, Analgesia, Epidural

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lumbar Epidural
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Analgesia, Obstetrical, Posture, Pregnancy, Female, Heart Rate, Fetal, Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Jim Pattison Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Left Uterine Displacement

Left Lateral

Right Lateral

Upright

Arm Description

Supine with left tilt for uterine displacement

Left lateral decubitus position

Right lateral decubitus position

Upright seated position

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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.
Events of fetal bradycardia after epidural placement
Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement.

Full Information

First Posted
June 30, 2020
Last Updated
October 8, 2021
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT04469101
Brief Title
A Study on the Effect of Position on Walking Labour Epidural Efficacy
Official Title
Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Analgesia, Epidural
Keywords
Analgesia, Obstetrical, Posture, Pregnancy, Female, Heart Rate, Fetal, Hypotension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left Uterine Displacement
Arm Type
Experimental
Arm Description
Supine with left tilt for uterine displacement
Arm Title
Left Lateral
Arm Type
Experimental
Arm Description
Left lateral decubitus position
Arm Title
Right Lateral
Arm Type
Experimental
Arm Description
Right lateral decubitus position
Arm Title
Upright
Arm Type
Experimental
Arm Description
Upright seated position
Intervention Type
Procedure
Intervention Name(s)
Lumbar Epidural
Intervention Description
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.
Primary Outcome Measure Information:
Title
Labour pain based on verbal rating pain scale
Description
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.
Time Frame
Taken at time 0 minutes after epidural insertion
Title
Labour pain based on verbal rating pain scale
Description
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.
Time Frame
Taken at time 20 minutes after epidural insertion
Title
Labour pain based on verbal rating pain scale
Description
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.
Time Frame
Taken at time 40 minutes after epidural insertion
Secondary Outcome Measure Information:
Title
Assessment of epidural levels based on dermatomes
Description
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.
Time Frame
Taken at time 20 minutes after epidural insertion
Title
Assessment of epidural levels based on dermatomes
Description
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.
Time Frame
Taken at time 40 minutes after epidural insertion
Title
Category of epidural based on bilateral dermatome levels
Description
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.
Time Frame
Taken at time 20 minutes after epidural insertion
Title
Category of epidural based on bilateral dermatome levels
Description
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
Time Frame
Taken at time 40 minutes after epidural insertion
Title
Events of maternal hypotension after epidural placement
Description
Hypotensive events defined as a deviation of greater than 20% of maternal blood pressure compared to pre-epidural baseline.
Time Frame
Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion
Title
Events of fetal bradycardia after epidural placement
Description
Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement.
Time Frame
Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica San Vicente, MD
Phone
306-655-1183
Email
mks773@mail.usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Stathakis, MD
Phone
902-456-0391
Email
alex.stathakis@usask.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica San Vicente, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jim Pattison Children's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1M6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica San Vicente, MD
Phone
306-655-1183
Email
mks773@mail.usask.ca
First Name & Middle Initial & Last Name & Degree
Alex Stathakis, MD
Phone
306-655-1183
Email
alex.stathakis@usask.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12707152
Citation
Halpern SH, Walsh V. Epidural ropivacaine versus bupivacaine for labor: a meta-analysis. Anesth Analg. 2003 May;96(5):1473-1479. doi: 10.1213/01.ANE.0000052383.01056.8F.
Results Reference
background
PubMed Identifier
29046273
Citation
Epidural and Position Trial Collaborative Group. Upright versus lying down position in second stage of labour in nulliparous women with low dose epidural: BUMPES randomised controlled trial. BMJ. 2017 Oct 18;359:j4471. doi: 10.1136/bmj.j4471.
Results Reference
background
PubMed Identifier
7378230
Citation
Husemeyer RP, White DC. Lumbar extradural injection pressures in pregnant women. An investigation of relationships between rate of infection, injection pressures and extent of analgesia. Br J Anaesth. 1980 Jan;52(1):55-60. doi: 10.1093/bja/52.1.55.
Results Reference
background
PubMed Identifier
7618719
Citation
Beilin Y, Bernstein HH, Zucker-Pinchoff B. The optimal distance that a multiorifice epidural catheter should be threaded into the epidural space. Anesth Analg. 1995 Aug;81(2):301-4. doi: 10.1097/00000539-199508000-00016.
Results Reference
background
PubMed Identifier
16434183
Citation
de la Chapelle A, Carles M, Gleize V, Dellamonica J, Lallia A, Bongain A, Raucoules-Aime M. Impact of walking epidural analgesia on obstetric outcome of nulliparous women in spontaneous labour. Int J Obstet Anesth. 2006 Apr;15(2):104-8. doi: 10.1016/j.ijoa.2005.07.002. Epub 2006 Jan 24.
Results Reference
result
PubMed Identifier
7196172
Citation
Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
Results Reference
result
PubMed Identifier
564647
Citation
Grundy EM, Rao LN, Winnie AP. Epidural anesthesia and the lateral position. Anesth Analg. 1978 Jan-Feb;57(1):95-7. doi: 10.1213/00000539-197801000-00017.
Results Reference
result
PubMed Identifier
11132738
Citation
Beilin Y, Abramovitz SE, Zahn J, Enis S, Hossain S. Improved epidural analgesia in the parturient in the 30 degree tilt position. Can J Anaesth. 2000 Dec;47(12):1176-81. doi: 10.1007/BF03019865.
Results Reference
result
PubMed Identifier
15321207
Citation
Shapiro A, Fredman B, Zohar E, Olsfanger D, Abu-Ras H, Jedeikin R. Alternating patient position following the induction of obstetric epidural analgesia does not affect local anaesthetic spread. Int J Obstet Anesth. 1998 Jul;7(3):153-6. doi: 10.1016/s0959-289x(98)80002-2.
Results Reference
result

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

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