Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery
Condition: Surgical Anesthesia, Cesarean Section
Study type: Interventional
Phase: Early Phase 1

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).
    

Intervention name(s): 2% Lidocaine; 3% Chloroprocaine
Intervention type(s): Drug; Drug
Intervention description(s): 2% Lidocaine using a combined spinal-epidural (CSE); 3% Chloroprocaine using a combined spinal-epidural (CSE)
Other intervention name(s): Xylocaine; Nesacaine
Intervention MeSH terms: Lidocaine; Chloroprocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment