Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery

NCT ID: NCT03414359

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2019-03-27

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).

Conditions

Surgical Anesthesia, Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

2% Lidocaine

Intervention Type: DRUG

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

3% Chloroprocaine

20 ml of 3% chloroprocaine with 4 ml 0.9% sodium chloride

Group Type: EXPERIMENTAL

3% Chloroprocaine

Intervention Type: DRUG

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

Interventions

2% Lidocaine

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

Intervention Type: DRUG

3% Chloroprocaine

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

Intervention Type: DRUG

Other Intervention Names

Xylocaine; Nesacaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadir Sharawi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32852294 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

207313

Identifier Type: -

Identifier Source: org_study_id