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Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).
Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).
A recent meta-analysis concluded that the optimum local anesthetic solution for extending a labor epidural from analgesia to surgical anesthesia has yet to be determined 2. In 1994, a retrospective study compared 1.5% lidocaine/bicarbonate/epinephrine mixture to 3% chloroprocaine in parturients with pre-existing epidural catheters for urgent cesarean delivery3. It was found that the chloroprocaine group had a significantly faster onset of anesthesia compared to the lidocaine group. Both drugs provided excellent anesthesia. However a high quality study comparing 3% chloroprocaine with 2% lidocaine/ epinephrine/ bicarbonate/ fentanyl (LEBF) in terms of anesthetic onset times has yet to be performed.
Women in labor frequently request an epidural to provide pain relief. Epidural pain relief is commonly provided by the administration of a low concentration of local anesthetic and opioid solution through an epidural catheter. This solution is delivered by an automated epidural infusion pump. In the event that a cesarean delivery is required, the pre-existing epidural is frequently used to administer a higher concentration anesthetic solution to allow pain free cesarean delivery. This is commonly referred to as an "epidural top up" or as an "extension of the epidural block." Standard practice at University of Arkansas for Medical Sciences (UAMS) for an epidural top up is Lidocaine, Epinephrine, Bicarbonate and Fentanyl (LEBF) or 3% chloroprocaine. These two mixtures are routinely and almost exclusively used for epidural cesarean delivery. The decision on which mixture to use is based solely on physician preference. It is likely that the LBEF mixture is used more frequently but the investigators consider both local anesthetic mixtures as equals and the standard of care at UAMS. The investigators do not use any other local anesthetics (unless there are very specific reasons).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Lidocaine | Active Comparator | Group LEBF received 20 ml of 2% lidocaine (combined with the following adjuncts [0.15 ml of 0.1% epinephrine, 2 ml of 8.4% sodium bicarbonate and 2 ml of 100 mcg fentanyl](streamdown:incomplete-link) |
|
| 3% Chloroprocaine | Experimental | 20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Lidocaine | Drug | 2% Lidocaine using a combined spinal-epidural (CSE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Onset Time to Surgical Anesthesia | The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori. | Up to 35 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation | This requirement for any rescue medications to control discomfort or pain during CD | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
Any mother requiring an elective cesarean section.
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| Name | Affiliation | Role |
|---|---|---|
| Nadir Sharawi, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32852294 | Derived | Sharawi N, Bansal P, Williams M, Spencer H, Mhyre JM. Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study. Anesth Analg. 2021 Mar 1;132(3):666-675. doi: 10.1213/ANE.0000000000005141. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Lidocaine | 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE) |
| FG001 | 3% Chloroprocaine | 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% Lidocaine | 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE) |
| BG001 | 3% Chloroprocaine | 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Onset Time to Surgical Anesthesia | The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori. | Per protocol analysis | Posted | Mean | Standard Deviation | seconds | Up to 35 minutes |
|
During inpatient admission, approximately three days
local anesthetic systemic toxicity (LAST), post-dural puncture headache (PDPH) and high spinal (defined as upper limb weakness)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2% Lidocaine | 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post dural puncture headache | Nervous system disorders | Non-systematic Assessment | presumed post-dural puncture headache due to spinal needle, treated with epidural blood batch |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadir El Sharawi | UAMS | 5016866114 | nelsharawi@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2018 | Mar 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C004616 | chloroprocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 3% Chloroprocaine | Drug | 3% Chloroprocaine using a combined spinal-epidural (CSE) |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Gestational age | Median | Inter-Quartile Range | days |
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| Duration of epidural infusion | Median | Inter-Quartile Range | minutes |
|
3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
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|
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| Secondary | Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation | This requirement for any rescue medications to control discomfort or pain during CD | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 3% Chloroprocaine | 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE) | 0 | 33 | 0 | 33 | 1 | 33 |
|
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| Aniline Compounds |
| D000588 | Amines |