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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469101
• Other study ID #: Bio 1813
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: October 2022

Study information

• Verified date: October 2021
• Source: University of Saskatchewan
• Contact: Monica San Vicente, MD
• Phone: 306-655-1183
• Email: mks773[@]mail.usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia, Epidural
• Labor Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Jim Pattison Children's Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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

de la Chapelle A, Carles M, Gleize V, Dellamonica J, Lallia A, Bongain A, Raucoules-Aimé 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. Epub 2006 Jan 24. — View 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. — View Citation

Grundy EM, Rao LN, Winnie AP. Epidural anesthesia and the lateral position. Anesth Analg. 1978 Jan-Feb;57(1):95-7. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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