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TC02 Obese Women Using It Morphine vs PCA IV Hydromorphone for Post-Cesarean Analgesia

Primary Purpose

Pain, Postoperative, Obesity, Respiratory Insufficiency

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intrathecal Morphine
Intravenous hydromorphone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pregnancy, Transcutaneous Carbon Dioxide Monitoring, Pulse Oximetry, Cesarean Section, Postoperative pain control, High BMI, Hypercarbia, Hypoxemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Term (≥37 week's gestation)
  • Healthy
  • ASA class 2-3
  • BMI ≥40kg/m2 scheduled for elective cesarean section whose anesthetic plan is for neuraxial anesthesia (spinal or combined-spinal epidural technique)

Exclusion Criteria:

  • Women with ASA >3,
  • BMI <40 kg/m2
  • Allergy to any of the medications used for pain control
  • Contraindication to the spinal anesthetic technique
  • Known sleep apnea or other sleep disordered breathing
  • Regular use of other medications that cause respiratory depression (ie. benzodiazepines).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intrathecal Morphine

    Intravenous Hydromorphone

    Arm Description

    Administration of 100µg intrathecal morphine to be given in the operative area.

    Administration of intravenous hydromorphone give IV pca in the post operative area.

    Outcomes

    Primary Outcome Measures

    Incidence of hypercapnia
    Incidence of hypercapnia (transcutaneous CO2 levels >50mmHg) in the intrathecal morphine versus patient controlled intravenous morphine groups

    Secondary Outcome Measures

    Opioid consumption
    Amount of opioids used during the time from delivery to 24 hours post delivery
    NSAID consumption
    Amount of NSAID's used during the time from delivery to 24 hours post delivery.
    Respiratory rate
    Hourly respiratory rates for the first 12 hours then every 2 hours for the next 12 hours.
    Sedation scores
    Sedation scores as scored on the Richmond Agitation and Sedation Scale at 2 hours, 6 hour and 12 hours post delivery.
    Pain Scores
    Pain scores on a scale of 0 (low)-10 (high) will be documented every hour for the first 24 hours after delivery.
    Pulse oximetry
    Pulse oximetry will be collected using the transcutaneous Co2 monitor for 24 hours after deliuvery.

    Full Information

    First Posted
    September 12, 2017
    Last Updated
    May 5, 2022
    Sponsor
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03282669
    Brief Title
    TC02 Obese Women Using It Morphine vs PCA IV Hydromorphone for Post-Cesarean Analgesia
    Official Title
    Randomized Controlled Trial Evaluating the Transcutaneous Carbon Dioxide Measurements in Obese Women Using Intrathecal Morphine Versus Patient-Controlled Intravenous Hydromorphone for Post-Cesarean Analgesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in institutional policy. Change in resources available.
    Study Start Date
    August 2019 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cesarean deliveries are the most commonly performed surgery in the United States and account for 32.9% of all births.8,9 The ASA recommends the use of neuraxial opioids of post-cesarean analgesia partly because respiratory depression in the obstetric population, as measured by intermittent respiratory rate and pulse oximetry, is reported to be low (0-1.2%).10,11 Respiratory depression lacks a standard definition,12 but the most sensitive means of detecting respiratory depression is hypercapnia.1,3 Two recent studies using continuous hypercapnia (>50mmHg PaCO2) monitoring demonstrated higher rates of respiratory depression (17.8-37%) in healthy, non-obese women receiving intrathecal opioids for post-cesarean analgesia.13,14 In addition, supplemental opioids are required in the majority of women receiving intrathecal morphine and may increase the risk of respiratory depression.11,14 Anesthesiologists debate whether neuraxial opioids or intravenous patient controlled opioid analgesia (PCA) are the safest practice for postoperative analgesia in obese parturients following cesarean delivery. The ASA recommendations to employ neuraxial analgesia post-cesarean delivery does not differentiate between non-obese and obese women who now make up 30.3% in US women of child-bearing age.2 Obesity has been described as a risk factor for respiratory depression in those receiving opioids via any route of opioid administration,11,15, 17 but whether obesity itself is the risk factor or associated co-morbidities such as sleep apnea is debated. Studies are conflicting whether intrathecal opioids or patient controlled intravenous opioids cause more respiratory depression. Several studies have documented the incidence of respiratory depression with IV PCA; the rates range from 0.19% to 5.2%, which are equivalent or higher than those reported for intrathecal opioids. (Hagle 16). Dalchow et al. demonstrated higher rates of hypercapnia in patients receiving intrathecal opioid compared with those receiving intravenous opioid via patient controlled analgesia in nonobese women following cesarean delivery. (Dalchow) The Topological Oscillation Search with Kinematical Analysis (TOSCA) monitor allows a noninvasive method to measure transcutaneous carbon dioxide levels, with relative accuracy compared to arterial carbon dioxide monitoring.4-7 No studies have examined transcutaneous carbon dioxide levels in obese women following cesarean delivery using any form of postoperative analgesia. The investigators propose a randomized controlled trial using continuous transcutaneous carbon dioxide monitoring to evaluate the degree of respiratory depression in obese women receiving neuraxial opioid compared to intravenous opioid via PCA for post-cesarean analgesia. Two studies have demonstrated high rates of hypercapnia in non-obese women following administration of intrathecal morphine for cesarean delivery in the postpartum period. (Dalchow, Bauchat) Dalchow et al. demonstrated higher rates of hypercapnia in women receiving intrathecal diamorphine than intravenous morphine delivered via patient controlled analgesia. It is unclear whether intrathecal morphine causes more or less respiratory depression than intravenous opioid delivered via patient-controlled analgesia in obese women. This study will add to the understanding of respiratory function in the immediate postpartum period in obese women using opioids via intrathecal or intravenous routes. This study will better inform guidelines for the postpartum analgesic route of choice in the obese obstetric population and allow the investigators to make recommendations for the detection and prevention of respiratory depression after opioid administration in the obstetric population. Objective is to examine the transcutaneous carbon dioxide levels in obese women using either intrathecal morphine or intravenous patient-controlled hydromorphone for post-cesarean analgesia. The hypothesis is carbon dioxide levels will be significantly higher in obese women receiving intrathecal morphine versus obese women receiving intravenous patient controlled intravenous hydromorphone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Obesity, Respiratory Insufficiency
    Keywords
    Pregnancy, Transcutaneous Carbon Dioxide Monitoring, Pulse Oximetry, Cesarean Section, Postoperative pain control, High BMI, Hypercarbia, Hypoxemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrathecal Morphine
    Arm Type
    Active Comparator
    Arm Description
    Administration of 100µg intrathecal morphine to be given in the operative area.
    Arm Title
    Intravenous Hydromorphone
    Arm Type
    Active Comparator
    Arm Description
    Administration of intravenous hydromorphone give IV pca in the post operative area.
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal Morphine
    Intervention Description
    Intrathecal Morphine administered in the operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous hydromorphone
    Intervention Description
    Intravenous hydromorphone administered via IV in the post operative area.
    Primary Outcome Measure Information:
    Title
    Incidence of hypercapnia
    Description
    Incidence of hypercapnia (transcutaneous CO2 levels >50mmHg) in the intrathecal morphine versus patient controlled intravenous morphine groups
    Time Frame
    24 hours post delivery
    Secondary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    Amount of opioids used during the time from delivery to 24 hours post delivery
    Time Frame
    24 hours post delivery
    Title
    NSAID consumption
    Description
    Amount of NSAID's used during the time from delivery to 24 hours post delivery.
    Time Frame
    24 hours post delivery
    Title
    Respiratory rate
    Description
    Hourly respiratory rates for the first 12 hours then every 2 hours for the next 12 hours.
    Time Frame
    24 hours post delivery
    Title
    Sedation scores
    Description
    Sedation scores as scored on the Richmond Agitation and Sedation Scale at 2 hours, 6 hour and 12 hours post delivery.
    Time Frame
    delivery to 12 hours post delivery
    Title
    Pain Scores
    Description
    Pain scores on a scale of 0 (low)-10 (high) will be documented every hour for the first 24 hours after delivery.
    Time Frame
    24 hours
    Title
    Pulse oximetry
    Description
    Pulse oximetry will be collected using the transcutaneous Co2 monitor for 24 hours after deliuvery.
    Time Frame
    24 hours post delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Term (≥37 week's gestation) Healthy ASA class 2-3 BMI ≥40kg/m2 scheduled for elective cesarean section whose anesthetic plan is for neuraxial anesthesia (spinal or combined-spinal epidural technique) Exclusion Criteria: Women with ASA >3, BMI <40 kg/m2 Allergy to any of the medications used for pain control Contraindication to the spinal anesthetic technique Known sleep apnea or other sleep disordered breathing Regular use of other medications that cause respiratory depression (ie. benzodiazepines).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Feyce Peralta, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25536092
    Citation
    Lee LA, Caplan RA, Stephens LS, Posner KL, Terman GW, Voepel-Lewis T, Domino KB. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015 Mar;122(3):659-65. doi: 10.1097/ALN.0000000000000564.
    Results Reference
    result
    PubMed Identifier
    24570244
    Citation
    Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
    Results Reference
    result
    PubMed Identifier
    26655725
    Citation
    Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration: An Updated Report by the American Society of Anesthesiologists Task Force on Neuraxial Opioids and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2016 Mar;124(3):535-52. doi: 10.1097/ALN.0000000000000975. No abstract available.
    Results Reference
    result
    PubMed Identifier
    18699897
    Citation
    McCormack JG, Kelly KP, Wedgwood J, Lyon R. The effects of different analgesic regimens on transcutaneous CO2 after major surgery. Anaesthesia. 2008 Aug;63(8):814-21. doi: 10.1111/j.1365-2044.2008.05487.x.
    Results Reference
    result

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    TC02 Obese Women Using It Morphine vs PCA IV Hydromorphone for Post-Cesarean Analgesia

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