Labor PainNCT04469101
A Study on the Effect of Position on Walking Labour Epidural Efficacy
A study testing Lumbar Epidural in people with Labor Pain and Analgesia, Epidural, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Analgesia, Epidural
- What is being tested?
- Lumbar Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active labour or admitted for induction of labour
- Requesting an epidural for labour analgesia
- Contractions occurring greater than once every 5 minutes
Who cannot join
- Coagulation disorder
- High risk pregnancy as per obstetrics
- Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7K 1M6
Monica San Vicente, MD, 306-655-1183, mks773@mail.usask.ca
Alex Stathakis, MD, 306-655-1183, alex.stathakis@usask.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Labor Pain, Analgesia, Epidural
- Being tested
- Lumbar Epidural
- Keywords
- Analgesia, Obstetrical, Posture, Pregnancy, Female, Heart Rate, Fetal, Hypotension
- Medical subject headings
- Labor Pain, Agnosia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar EpiduralProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Left Uterine Displacement | Experimental | Supine with left tilt for uterine displacement Receives: Procedure: Lumbar Epidural |
| Left Lateral | Experimental | Left lateral decubitus position Receives: Procedure: Lumbar Epidural |
| Right Lateral | Experimental | Right lateral decubitus position Receives: Procedure: Lumbar Epidural |
| Upright | Experimental | Upright seated position Receives: Procedure: Lumbar Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Taken at time 40 minutes after epidural insertion
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start31 May 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica San Vicente, University of Saskatchewan
- Investigators
- Monica San Vicente, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469101
- Sponsor's protocol ID
- Bio 1813
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2020
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12707152Epidural 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.
PubMed 29046273Husemeyer 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.
PubMed 7378230Beilin 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.
PubMed 7618719de 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.
PubMed 16434183Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
PubMed 7196172Grundy 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.
PubMed 564647Beilin 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.
PubMed 11132738Shapiro 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.
PubMed 15321207
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia
- ClinicalTrials.gov ID
- NCT04469101
- Acronym / sponsor ID
- Bio 1813
- Conditions
- Labor Pain, Analgesia, Epidural
- Keywords
- Analgesia, Obstetrical, Posture, Pregnancy, Female, Heart Rate, Fetal, Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Left Uterine Displacement | Experimental | Procedure: Lumbar EpiduralSupine with left tilt for uterine displacement |
| Left Lateral | Experimental | Procedure: Lumbar EpiduralLeft lateral decubitus position |
| Right Lateral | Experimental | Procedure: Lumbar EpiduralRight lateral decubitus position |
| Upright | Experimental | Procedure: Lumbar EpiduralUpright seated position |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active labour or admitted for induction of labour
- Requesting an epidural for labour analgesia
- Contractions occurring greater than once every 5 minutes
Key exclusion criteria (3 listed)
- Coagulation disorder
- High risk pregnancy as per obstetrics
- Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar EpiduralParturients 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. | Procedure or surgery | Left Lateral, Left Uterine Displacement, Right Lateral, Upright |
Primary outcome
Labour pain based on verbal rating pain scale
Time frame: Taken at time 0 minutes after epidural insertion
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
Time frame: Taken at time 20 minutes after epidural insertion
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
Time frame: Taken at time 40 minutes after epidural insertion
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.
6 secondary outcomes
Assessment of epidural levels based on dermatomes
Time frame: Taken at time 20 minutes after epidural insertion
Assessment of epidural levels based on dermatomes
Time frame: Taken at time 40 minutes after epidural insertion
Category of epidural based on bilateral dermatome levels
Time frame: Taken at time 20 minutes after epidural insertion
Category of epidural based on bilateral dermatome levels
Time frame: Taken at time 40 minutes after epidural insertion
Events of maternal hypotension after epidural placement
Time frame: 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
Time frame: Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 12707152Halpern 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.
- Background: PubMed 29046273Epidural 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.
- Background: PubMed 7378230Husemeyer 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.
- Background: PubMed 7618719Beilin 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 publication: PubMed 16434183de 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 publication: PubMed 7196172Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
- Results publication: PubMed 564647Grundy 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 publication: PubMed 11132738Beilin 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 publication: PubMed 15321207Shapiro 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.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica San Vicente, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Epidural in people with Labor Pain and Analgesia, Epidural, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica San Vicente, MD (306-655-1183, mks773@mail.usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labour pain based on verbal rating pain scale (time frame: Taken at time 0 minutes after epidural insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469101, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.