NCT04469101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

June 30, 2020

Last Update Submit

October 8, 2021

Conditions

Labor PainAnalgesia, Epidural

Keywords

Analgesia, ObstetricalPosturePregnancyFemaleHeart Rate, FetalHypotension

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Assessment of epidural levels based on dermatomes

    Taken at time 20 minutes after epidural insertion

  • Assessment of epidural levels based on dermatomes

    Taken at time 40 minutes after epidural insertion

  • Category of epidural based on bilateral dermatome levels

    Taken at time 20 minutes after epidural insertion

  • Category of epidural based on bilateral dermatome levels

    Taken at time 40 minutes after epidural insertion

  • Events of maternal hypotension after epidural placement

    Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion

  • +1 more secondary outcomes

Study Arms (4)

Left Uterine Displacement

EXPERIMENTAL

Supine with left tilt for uterine displacement

Procedure: Lumbar Epidural

Left Lateral

EXPERIMENTAL

Left lateral decubitus position

Procedure: Lumbar Epidural

Right Lateral

EXPERIMENTAL

Right lateral decubitus position

Procedure: Lumbar Epidural

Upright

EXPERIMENTAL

Upright seated position

Procedure: Lumbar Epidural

Interventions

Lumbar EpiduralPROCEDURE

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.

Left LateralLeft Uterine DisplacementRight LateralUpright

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active labour or admitted for induction of labour
  • Requesting an epidural for labour analgesia
  • Contractions occurring greater than once every 5 minutes

You may not qualify if:

  • Coagulation disorder
  • High risk pregnancy as per obstetrics
  • Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7K 1M6, Canada

RECRUITING

Related Publications (9)

  • 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.

    PMID: 12707152BACKGROUND

  • 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.

    PMID: 29046273BACKGROUND

  • 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.

    PMID: 7378230BACKGROUND

  • 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.

    PMID: 7618719BACKGROUND

  • 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.

    PMID: 16434183RESULT

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

    PMID: 7196172RESULT

  • 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.

    PMID: 564647RESULT

  • 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.

    PMID: 11132738RESULT

  • 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.

    PMID: 15321207RESULT

MeSH Terms

Conditions

Labor PainAgnosiaHypotension

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Monica San Vicente, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica San Vicente, MD

CONTACT

306-655-1183mks773@mail.usask.ca

Alex Stathakis, MD

CONTACT

902-456-0391alex.stathakis@usask.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 13, 2020

Study Start

May 31, 2021

Primary Completion

July 1, 2022

Study Completion

October 1, 2022

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)