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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain; Analgesia, Epidural
• Intervention / Treatment: Procedure: Lumbar Epidural

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.

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica San Vicente, MD; Phone Number: 306-655-1183; Email: mks773@mail.usask.ca
• Study Contact Backup: Name: Alex Stathakis, MD; Phone Number: 902-456-0391; Email: alex.stathakis@usask.ca

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 1M6
      • Recruiting
      • Jim Pattison Children's Hospital
      • Contact: Monica San Vicente, MD; Phone Number: 306-655-1183; Email: mks773@mail.usask.ca
      • Contact: Alex Stathakis, MD; Phone Number: 306-655-1183; Email: alex.stathakis@usask.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Uterine Displacement; Supine with left tilt for uterine displacement	Procedure: Lumbar Epidural; 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.
Experimental: Left Lateral; Left lateral decubitus position	Procedure: Lumbar Epidural; 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.
Experimental: Right Lateral; Right lateral decubitus position	Procedure: Lumbar Epidural; 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.
Experimental: Upright; Upright seated position	Procedure: Lumbar Epidural; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Monica San Vicente, MD, University of Saskatchewan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Hypotension; Posture; Female; Heart Rate, Fetal; Analgesia, Obstetrical
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: Bio 1813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No