Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
NCT ID: NCT04369950
Last Updated: 2022-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2020-05-11
2021-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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2 percent Lidocaine with epinephrine and epidural morphine
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.
3 percent 2-Chloroprocaine and epidural morphine
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* live singleton pregnancy
Exclusion Criteria
* obstructive sleep apnea
* drug abuse
* chronic pain
* chronic opioid use
* nonfunctioning epidural
18 Years
50 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Linden Lee
Assistant Professor
Principal Investigators
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Linden Lee, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-19-0951
Identifier Type: -
Identifier Source: org_study_id
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