Clinical trial NCT04469101: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Analgesia, Epidural
Keywords: Analgesia, Obstetrical
Posture
Pregnancy
Female
Heart Rate, Fetal
Hypotension
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Labour pain based on verbal rating pain scale
timeFrame: Taken at time 0 minutes after epidural insertion
measure: Labour pain based on verbal rating pain scale
timeFrame: Taken at time 20 minutes after epidural insertion
measure: Labour pain based on verbal rating pain scale
timeFrame: Taken at time 40 minutes after epidural insertion
Secondary outcomes:
measure: Assessment of epidural levels based on dermatomes
timeFrame: Taken at time 20 minutes after epidural insertion
measure: Assessment of epidural levels based on dermatomes
timeFrame: Taken at time 40 minutes after epidural insertion
measure: Category of epidural based on bilateral dermatome levels
timeFrame: Taken at time 20 minutes after epidural insertion
measure: Category of epidural based on bilateral dermatome levels
timeFrame: Taken at time 40 minutes after epidural insertion
measure: Events of maternal hypotension after epidural placement
timeFrame: Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion
measure: Events of fetal bradycardia after epidural placement
timeFrame: Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Monica San Vicente, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
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.
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.
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.