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Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369950
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Linden Lee, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h

Condition or disease Intervention/treatment Phase
Physiological Effect of Drugs Morphine Analgesics Analgesics, Opioid Central Nervous System Depressants Narcotics Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine Drug: 3% 2-chloroprocaine and epidural morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Estimated Study Start Date : May 11, 2020
Estimated Primary Completion Date : May 11, 2021
Estimated Study Completion Date : July 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2 percent Lidocaine with epinephrine and epidural morphine Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine
Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.

Experimental: 3 percent 2-Chloroprocaine and epidural morphine Drug: 3% 2-chloroprocaine and epidural morphine
Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.




Primary Outcome Measures :
  1. total amount of opioid used [ Time Frame: 4 hours after epidural morphine administration ]
  2. total amount of opioid used [ Time Frame: 8 hours after epidural morphine administration ]
  3. total amount of opioid used [ Time Frame: 12 hours after epidural morphine administration ]
  4. total amount of opioid used [ Time Frame: 24 hours after epidural morphine administration ]
  5. total amount of opioid used [ Time Frame: 36 hours after epidural morphine administration ]

Secondary Outcome Measures :
  1. Pain as measured by a 11 point verbal scale [ Time Frame: every 4 hours for the first 12 hours,every 12 hours for the next 24 hours ]
    scale ranges form 0-10,higher number indicating more pain

  2. Nausea as measured by a 3 point scale [ Time Frame: every 4 hours for the first 12 hours,every 12 hours for the next 24 hours ]
    scale ranges from non,mild and moderate-severe

  3. Pruritis as measured by a 3 point scale [ Time Frame: every 4 hours for the first 12 hours,every 12 hours for the next 24 hours ]
    scale ranges from non,mild and moderate-severe



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant patients
  • live singleton pregnancy

Exclusion Criteria:

  • BMI >40
  • obstructive sleep apnea
  • drug abuse
  • chronic pain
  • chronic opioid use
  • nonfunctioning epidural

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): NCT04369950


Contacts
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Contact: Linden Lee, MD (713) 500-6200 Linden.O.Lee@uth.tmc.edu
Contact: Ana Lisa Ramirez-Chapman, MD (713) 566-5971 Ana.L.RamirezChapman@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Linden Lee, MD    713-500-6200    Linden.O.Lee@uth.tmc.edu   
Contact: Ana Lisa Ramirez-Chapman, MD    (713) 566-5971    Ana.L.RamirezChapman@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Linden Lee, MD The University of Texas Health Science Center, Houston
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Responsible Party: Linden Lee, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04369950    
Other Study ID Numbers: HSC-MS-19-0951
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
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 Linden Lee, The University of Texas Health Science Center, Houston:
cesarean delivery
c-section
chloroprocaine
lidocaine
morphine
post-operative pain
post-cesarean analgesia
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Morphine
Chloroprocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents