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

Study Overview
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Brief Summary
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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

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

Conditions
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Physiological Effect of Drugs, Morphine, Analgesics, Analgesics, Opioid, Central Nervous System Depressants, Narcotics

Intervention / Treatment
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* Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine
* Drug: 3% 2-chloroprocaine and epidural morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant patients live singleton pregnancy Exclusion Criteria: BMI >40 obstructive sleep apnea drug abuse chronic pain chronic opioid use nonfunctioning epidural

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 percent Lidocaine with epinephrine and epidural morphine<br> | Drug: 2% lidocaine with 1:200,000 epinephrine and epidural morphine<br>* 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.<br>|
| Experimental: 3 percent 2-Chloroprocaine and epidural morphine<br> | Drug: 3% 2-chloroprocaine and epidural morphine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Opioid Used |  | 24 hours after epidural morphine administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Opioid Used |  | 12 hours after epidural morphine administration | 
| Total Amount of Opioid Used |  | 8 hours after epidural morphine administration | 
| Total Amount of Opioid Used |  | 4 hours after epidural morphine administration | 
| Pain as Measured by a 11 Point Verbal Scale | scale ranges form 0-10, higher number indicating more pain | 4,8, 12 and 24 hours after epidural morphine administration | 
| Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | scale ranges from non,mild and moderate-severe | 4,8, 12 and 24 hours after epidural morphine administration | 
| Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | scale ranges from non,mild and moderate-severe | 4,8, 12 and 24 hours after epidural morphine administration | 
| Time Until First Opioid Request |  | Up to 48 hours after epidural morphine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean delivery, c-section, chloroprocaine, lidocaine, morphine, post-operative pain, post-cesarean analgesia