Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery
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| ClinicalTrials.gov Identifier: NCT03414359 |
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Recruitment Status :
Completed
First Posted : January 29, 2018
Results First Posted : April 13, 2020
Last Update Posted : April 13, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgical Anesthesia, Cesarean Section | Drug: 2% Lidocaine Drug: 3% Chloroprocaine | Early Phase 1 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind Study Comparing 3% Chloroprocaine Versus 2 % Lidocaine/ Epinephrine/ Bicarbonate/ Fentanyl for Epidural Anesthesia in Elective Cesarean Delivery |
| Actual Study Start Date : | February 15, 2018 |
| Actual Primary Completion Date : | March 27, 2019 |
| Actual Study Completion Date : | March 27, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 2% Lidocaine
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
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Drug: 2% Lidocaine
2% Lidocaine using a combined spinal-epidural (CSE)
Other Name: Xylocaine |
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Experimental: 3% Chloroprocaine
20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride
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Drug: 3% Chloroprocaine
3% Chloroprocaine using a combined spinal-epidural (CSE)
Other Name: Nesacaine |
- The Onset Time to Surgical Anesthesia [ Time Frame: Up to 35 minutes ]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.
- Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation [ Time Frame: 1 hour ]This requirement for any rescue medications to control discomfort or pain during CD
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Any mother requiring an elective cesarean section. |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ≥ 18 years of age for the mother
- Singleton pregnancy
- Gestation > 36 weeks
- American Society of Anesthesiologist (ASA) class II
- Provides written consent
- Infant of mother
Exclusion Criteria:
- Patient refusal
- Non-elective or urgent/emergent cesarean sections
- ASA class III or above
- Unable to understand English
- Significant back surgery or scoliosis
- Known fetal abnormality
- Weight > 120 kg
- Height < 150 cm
- Allergy to local anesthetics
- Concurrent use of sulfonamides
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): NCT03414359
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Principal Investigator: | Nadir Sharawi, MD | University of Arkansas |
Documents provided by University of Arkansas:
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT03414359 |
| Other Study ID Numbers: |
207313 |
| First Posted: | January 29, 2018 Key Record Dates |
| Results First Posted: | April 13, 2020 |
| Last Update Posted: | April 13, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Lidocaine 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 |