Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Study Overview
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Brief Summary
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This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

Detailed Description
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This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg. Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as transient neurologic symptoms - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours. Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.

Official Title
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Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage

Conditions
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Adverse Reaction to Spinal Anesthetic, Maternal Care for Cervical Incompetence

Intervention / Treatment
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* Drug: Chloroprocaine
* Drug: Bupivacaine
* Drug: Fentanyl
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II women 18-45 yrs old Singleton pregnancy Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia Height 150 - 180 cm BMI ≤ 40 kg/m2. Exclusion Criteria: Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy) Pre-existing/chronic back pain Ester local anesthetic allergy, PABA allergy History of atypical cholinesterase (CP is metabolized by cholinesterase)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroprocaine (CP)<br>Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml) | Drug: Chloroprocaine<br>* Administered as a single injection or continuously through an indwelling catheter - 50 mg<br>* Other names: Nesacaine;Drug: Fentanyl<br>* 15 mcg Fentanyl will be included int he spinal anesthetic in both groups<br>* Other names: Sublimaze;|
| Active Comparator: Bupivacaine (BUP)<br>Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to   2 ml | Drug: Bupivacaine<br>* A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)<br>* Other names: Bupivacaine hydrochloride;Drug: Fentanyl<br>* 15 mcg Fentanyl will be included int he spinal anesthetic in both groups<br>* Other names: Sublimaze;Drug: Saline<br>* Preservative free normal saline (0.3 ml) to bring the volume to   2 ml<br>* Other names: Salt water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resolution of Motor Block | The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%) | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulate | Time from spinal anesthesia placement to ability to ambulate. | 5 hours | 
| Time to Void | Time from spinal anesthesia injection to ability to void spontaneously. | 5 hours | 

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