Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Tufts University

Status and phase: Completed; Phase 4

Conditions: Cervical Incompetence

Treatments: Drug: Chloroprocaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03305575

12619

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Chloroprocaine

Experimental group

Description:

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)

Treatment:

Drug: Chloroprocaine

Bupivacaine

Active Comparator group

Description:

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).

Treatment:

Drug: Bupivacaine