Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Study Overview
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Brief Summary
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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.

Detailed Description
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Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their use impacts clinical care, in particular patient flow, is not well studied. This is a prospective, randomized, double blind, controlled trial. Participants meeting inclusion criteria will be randomly allocated to receive spinal anesthesia with either chloroprocaine or bupivacaine. Patients will then be assessed for motor block and sensory level until they are discharged from the recovery room.

Official Title
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A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Conditions
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Cervical Incompetence

Intervention / Treatment
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* Drug: Chloroprocaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double blinded clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroprocaine<br>Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml) | Drug: Chloroprocaine<br>* 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.<br>* Other names: Sensorcaine;|
| Active Comparator: Bupivacaine<br>Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml). | Drug: Bupivacaine<br>* 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.<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Motor Block | The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Sensory Block | The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic. | 6 hours | 
| Time to Ambulation | The time difference between local anesthetic injection and patient's walking for the first time postoperatively. | 6 hours | 
| Time to Micturation | The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Chloroprocaine, spinal anesthesia, Cervical Cerclage