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Withdrawn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
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
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
NCT ID
NCT03282669
First Posted
September 12, 2017
Last Updated
May 5, 2022
Sponsor
Northwestern University
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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