Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Condition: Cervical Incompetence
MeSH terms: Uterine Cervical Incompetence
Intervention: Chloroprocaine; Bupivacaine
Intervention description: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.; The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
Intervention MeSH terms: Bupivacaine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double blinded clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient.
Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Cervical Cerclage; Bupivacaine; Chloroprocaine; spinal anesthesia

Summary:

      This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor
      block and duration until meeting discharge criteria in patients undergoing cervical cerclage.
      The hypothesis is that chloroprocaine will result in faster resolution of motor block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA classification II or III females

          -  Age: 18-45 years old

          -  BMI ≤ 50 kg/m2

          -  Singleton pregnancy

          -  Simple prophylactic cervical cerclage

          -  Planning neuraxial anesthesia

        Exclusion Criteria:

          -  Abdominal and complex cervical cerclage (e.g. bulging bag)

          -  Contraindication to neuraxial anesthesia

          -  Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid
             (PABA) or bupivacaine (a.k.a. Amide allergy)

          -  Pseudocholinesterase deficiency

          -  Concomitant use with ergot-type oxytocic drugs