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

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ClinicalTrials.gov Identifier: NCT03282669
Recruitment Status : Withdrawn (Change in institutional policy. Change in resources available.)
First Posted : September 14, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Feyce M. Peralta, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Obesity Respiratory Insufficiency Drug: Intrathecal Morphine Drug: Intravenous hydromorphone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intrathecal Morphine
Administration of 100µg intrathecal morphine to be given in the operative area.
Drug: Intrathecal Morphine
Intrathecal Morphine administered in the operating room.

Active Comparator: Intravenous Hydromorphone
Administration of intravenous hydromorphone give IV pca in the post operative area.
Drug: Intravenous hydromorphone
Intravenous hydromorphone administered via IV in the post operative area.




Primary Outcome Measures :
  1. Incidence of hypercapnia [ Time Frame: 24 hours post delivery ]
    Incidence of hypercapnia (transcutaneous CO2 levels >50mmHg) in the intrathecal morphine versus patient controlled intravenous morphine groups


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hours post delivery ]
    Amount of opioids used during the time from delivery to 24 hours post delivery

  2. NSAID consumption [ Time Frame: 24 hours post delivery ]
    Amount of NSAID's used during the time from delivery to 24 hours post delivery.

  3. Respiratory rate [ Time Frame: 24 hours post delivery ]
    Hourly respiratory rates for the first 12 hours then every 2 hours for the next 12 hours.

  4. Sedation scores [ Time Frame: delivery to 12 hours post delivery ]
    Sedation scores as scored on the Richmond Agitation and Sedation Scale at 2 hours, 6 hour and 12 hours post delivery.

  5. Pain Scores [ Time Frame: 24 hours ]
    Pain scores on a scale of 0 (low)-10 (high) will be documented every hour for the first 24 hours after delivery.

  6. Pulse oximetry [ Time Frame: 24 hours post delivery ]
    Pulse oximetry will be collected using the transcutaneous Co2 monitor for 24 hours after deliuvery.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282669


Locations
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United States, Illinois
Prentice Womens Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Feyce Peralta, MD Northwestern University
Publications of Results:
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Responsible Party: Feyce M. Peralta, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03282669    
Other Study ID Numbers: STU00203985
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feyce M. Peralta, Northwestern University:
Pregnancy
Transcutaneous Carbon Dioxide Monitoring
Pulse Oximetry
Cesarean Section
Postoperative pain control
High BMI
Hypercarbia
Hypoxemia
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents