An Early Phase 1 interventional study of 2% Lidocaine and 3% Chloroprocaine in Surgical Anesthesia, Cesarean Section, sponsored by University of Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-13.
Sponsored by University of Arkansas · Early Phase 1, Interventional, and Treatment
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).
University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: 2% Lidocaine
20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride
Drug: 3% Chloroprocaine
2% Lidocaine using a combined spinal-epidural (CSE)
Also known as: Xylocaine
3% Chloroprocaine using a combined spinal-epidural (CSE)
Also known as: Nesacaine
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.
Time frame: Up to 35 minutes
Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation
This requirement for any rescue medications to control discomfort or pain during CD
Time frame: 1 hour
| Milestone | 2% Lidocaine | 3% Chloroprocaine |
|---|---|---|
| Started | 35 | 35 |
| Completed | 34 | 33 |
| Not completed | 1 | 2 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| seconds | 2% Lidocaine | 3% Chloroprocaine |
|---|---|---|
| The Onset Time to Surgical Anesthesia | 558 ± 269 | 655 ± 258 |
This requirement for any rescue medications to control discomfort or pain during CD
| Participants | 2% Lidocaine | 3% Chloroprocaine |
|---|---|---|
| Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation | 4 | 7 |
Collected over During inpatient admission, approximately three days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2% Lidocaine | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| 3% Chloroprocaine | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) |
| Event | 2% Lidocaine | 3% Chloroprocaine |
|---|---|---|
| Post dural puncture headacheNervous system disorders | 0/34 | 1/33 |
| Age, Categorical(Participants) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 33 | 67 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| Median | 27 (24 to 32) | 30 (24 to 34) | 28 (24 to 33) |
| Sex: Female, Male(Participants) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| Female | 34 | 33 | 67 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| African American | 13 | 12 | 25 |
| Other | 21 | 21 | 42 |
| Region of Enrollment(participants) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| United States | 34 | 33 | 67 |
| BMI(kg/m^2) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| Median | 31 (27 to 37) | 32 (29 to 37) | 31 (28 to 37) |
| Gestational age(days) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| Median | 273 (273 to 275) | 273 (268 to 273) | 273 (270 to 274) |
| Duration of epidural infusion(minutes) | 2% Lidocaine | 3% Chloroprocaine | Total |
|---|---|---|---|
| Median | 48 (38 to 73) | 49 (36 to 70) | 49 (37 to 72) |
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Studies of the drug tested here: Chloroprocaine