<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469101</url>
  </required_header>
  <id_info>
    <org_study_id>Bio 1813</org_study_id>
    <nct_id>NCT04469101</nct_id>
  </id_info>
  <brief_title>A Study on the Effect of Position on Walking Labour Epidural Efficacy</brief_title>
  <official_title>Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to better understand how patient positioning can affect pain relief&#xD;
      after an epidural. In addition to pain, the investigators will assess how position affects&#xD;
      epidural spread, and its effects on maternal blood pressure and fetal heart rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidurals will be placed with parturients in the standard sitting position. An epidural&#xD;
      catheter will be placed to a depth of 5 cm into the epidural space. After placement,&#xD;
      parturients will be randomized to one of the four position groups (left uterine displacement,&#xD;
      left lateral, right lateral, or seated upright). After successful positioning, a series of 5&#xD;
      cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through&#xD;
      the epidural catheter in 5 minute intervals for a total volume of 20 cc. After the initial&#xD;
      loading dose of epidural solution has been injected in the first 20 minutes post-insertion,&#xD;
      the patient will be able to return to whatever position they are most comfortable with. The&#xD;
      parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the&#xD;
      peak of their contraction at three time intervals. The spread of the blockade will be&#xD;
      assessed with ice applied along both the left and right mid-clavicular lines. Maternal blood&#xD;
      pressure will be measured on the upper arm in all patients as per nursing protocol. Fetal&#xD;
      heart rate will be monitored intermittently with Doppler ultrasound as per nursing protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 31, 2021</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Labour pain based on verbal rating pain scale</measure>
    <time_frame>Taken at time 0 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Labour pain based on verbal rating pain scale</measure>
    <time_frame>Taken at time 20 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Labour pain based on verbal rating pain scale</measure>
    <time_frame>Taken at time 40 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of epidural levels based on dermatomes</measure>
    <time_frame>Taken at time 20 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of epidural levels based on dermatomes</measure>
    <time_frame>Taken at time 40 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Category of epidural based on bilateral dermatome levels</measure>
    <time_frame>Taken at time 20 minutes after epidural insertion</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Category of epidural based on bilateral dermatome levels</measure>
    <time_frame>Taken at time 40 minutes after epidural insertion</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events of maternal hypotension after epidural placement</measure>
    <time_frame>Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion</time_frame>
    <description>Hypotensive events defined as a deviation of greater than 20% of maternal blood pressure compared to pre-epidural baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Events of fetal bradycardia after epidural placement</measure>
    <time_frame>Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion</time_frame>
    <description>Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">216</enrollment>
  <condition>Labor Pain</condition>
  <condition>Analgesia, Epidural</condition>
  <arm_group>
    <arm_group_label>Left Uterine Displacement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supine with left tilt for uterine displacement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left Lateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Left lateral decubitus position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right Lateral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Right lateral decubitus position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upright</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Upright seated position</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar Epidural</intervention_name>
    <description>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.</description>
    <arm_group_label>Left Lateral</arm_group_label>
    <arm_group_label>Left Uterine Displacement</arm_group_label>
    <arm_group_label>Right Lateral</arm_group_label>
    <arm_group_label>Upright</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active labour or admitted for induction of labour&#xD;
&#xD;
          -  Requesting an epidural for labour analgesia&#xD;
&#xD;
          -  Contractions occurring greater than once every 5 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulation disorder&#xD;
&#xD;
          -  High risk pregnancy as per obstetrics&#xD;
&#xD;
          -  Spinal pathology (included scoliosis, herniated disks, or previous lumbar back&#xD;
             surgery)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica San Vicente, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Monica San Vicente, MD</last_name>
    <phone>306-655-1183</phone>
    <email>mks773@mail.usask.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alex Stathakis, MD</last_name>
    <phone>902-456-0391</phone>
    <email>alex.stathakis@usask.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jim Pattison Children's Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 1M6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica San Vicente, MD</last_name>
      <phone>306-655-1183</phone>
      <email>mks773@mail.usask.ca</email>
    </contact>
    <contact_backup>
      <last_name>Alex Stathakis, MD</last_name>
      <phone>306-655-1183</phone>
      <email>alex.stathakis@usask.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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>
    <PMID>12707152</PMID>
  </reference>
  <reference>
    <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>
    <PMID>29046273</PMID>
  </reference>
  <reference>
    <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>
    <PMID>7378230</PMID>
  </reference>
  <reference>
    <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>
    <PMID>7618719</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>16434183</PMID>
  </results_reference>
  <results_reference>
    <citation>Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.</citation>
    <PMID>7196172</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>564647</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>11132738</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15321207</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Monica San Vicente</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Analgesia, Obstetrical</keyword>
  <keyword>Posture</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Female</keyword>
  <keyword>Heart Rate, Fetal</keyword>
  <keyword>Hypotension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469101
org study id: Bio 1813
nct id: NCT04469101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Labour pain based on verbal rating pain scale
time frame: Taken at time 0 minutes after epidural insertion
description: 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.
measure: Labour pain based on verbal rating pain scale
time frame: Taken at time 20 minutes after epidural insertion
description: 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.
measure: Labour pain based on verbal rating pain scale
time frame: Taken at time 40 minutes after epidural insertion
description: 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.
measure: Assessment of epidural levels based on dermatomes
time frame: Taken at time 20 minutes after epidural insertion
description: 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.
measure: Assessment of epidural levels based on dermatomes
time frame: Taken at time 40 minutes after epidural insertion
description: 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.
measure: Category of epidural based on bilateral dermatome levels
time frame: Taken at time 20 minutes after epidural insertion
description: 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.
measure: Category of epidural based on bilateral dermatome levels
time frame: Taken at time 40 minutes after epidural insertion
description: 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
measure: 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
description: Hypotensive events defined as a deviation of greater than 20% of maternal blood pressure compared to pre-epidural baseline.
measure: 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
description: Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement.
arm group label: Left Uterine Displacement
arm group type: Experimental
description: Supine with left tilt for uterine displacement
arm group label: Left Lateral
arm group type: Experimental
description: Left lateral decubitus position
arm group label: Right Lateral
arm group type: Experimental
description: Right lateral decubitus position
arm group label: Upright
arm group type: Experimental
description: Upright seated position
intervention type: Procedure
intervention name: Lumbar Epidural
description: 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.
arm group label: Left Lateral
arm group label: Left Uterine Displacement
arm group label: Right Lateral
arm group label: Upright
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Monica San Vicente, MD
role: Principal Investigator
affiliation: University of Saskatchewan
last name: Monica San Vicente, MD
phone: 306-655-1183
email: mks773@mail.usask.ca
last name: Alex Stathakis, MD
phone: 902-456-0391
email: alex.stathakis@usask.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
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.
PMID: 12707152
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.
PMID: 29046273
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.
PMID: 7378230
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.
PMID: 7618719
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.
PMID: 16434183
citation: Apostolou GA, Zarmakoupis PK, Mastrokostopoulos GT. Spread of epidural anesthesia and the lateral position. Anesth Analg. 1981 Aug;60(8):584-6.
PMID: 7196172
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.
PMID: 564647
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.
PMID: 11132738
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.
PMID: 15321207
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Monica San Vicente
investigator title: Principal Investigator
mesh term: Labor Pain
sharing ipd: No