Skip to content

Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery

A Randomized, Double-blind Study Comparing 3% Chloroprocaine Versus 2 % Lidocaine/ Epinephrine/ Bicarbonate/ Fentanyl for Epidural Anesthesia in Elective Cesarean Delivery

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03414359
Enrollment
70
Registered
2018-01-29
Start date
2018-02-15
Completion date
2019-03-27
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Anesthesia, Cesarean Section

Brief summary

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).

Detailed description

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).

Interventions

2% Lidocaine using a combined spinal-epidural (CSE)

DRUG3% Chloroprocaine

3% Chloroprocaine using a combined spinal-epidural (CSE)

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The Onset Time to Surgical AnesthesiaUp to 35 minutesThe 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

MeasureTime frameDescription
Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation1 hourThis requirement for any rescue medications to control discomfort or pain during CD

Countries

United States

Participant flow

Participants by arm

ArmCount
2% Lidocaine
2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)
34
3% Chloroprocaine
3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
33
Total67

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy11
Overall StudyProtocol Violation01

Baseline characteristics

CharacteristicTotal3% Chloroprocaine2% Lidocaine
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
67 Participants33 Participants34 Participants
Age, Continuous28 years30 years27 years
BMI31 kg/m^232 kg/m^231 kg/m^2
Duration of epidural infusion49 minutes49 minutes48 minutes
Gestational age273 days273 days273 days
Race/Ethnicity, Customized
African American
25 participants12 participants13 participants
Race/Ethnicity, Customized
Other
42 participants21 participants21 participants
Region of Enrollment
United States
67 participants33 participants34 participants
Sex: Female, Male
Female
67 Participants33 Participants34 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 33
other
Total, other adverse events
0 / 341 / 33
serious
Total, serious adverse events
0 / 340 / 33

Outcome results

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.

Time frame: Up to 35 minutes

Population: Per protocol analysis

ArmMeasureValue (MEAN)Dispersion
2% LidocaineThe Onset Time to Surgical Anesthesia558 secondsStandard Deviation 269
3% ChloroprocaineThe Onset Time to Surgical Anesthesia655 secondsStandard Deviation 258
Comparison: To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.p-value: 0.1Wilcoxon (Mann-Whitney)
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

Time frame: 1 hour

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
2% LidocaineSecondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation4 Participants
3% ChloroprocaineSecondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation7 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026