Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Phase 4

Completed

• Conditions: Cervical Incompetence
• Interventions: Drug: Chloroprocaine; Drug: Bupivacaine

• Registration Number: NCT03305575
• Lead Sponsor: Tufts Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-10
• Study Start: 2017-10-13
• Primary Completion: 2018-08-24
• Study Completion: 2018-08-24
• Results First Submitted: 2019-09-10
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroprocaine	Chloroprocaine	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)
Bupivacaine	Bupivacaine	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).

Primary Outcome Measures

Name	Time	Method
Duration of Motor Block	6 hours	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

Secondary Outcome Measures

Name	Time	Method
Duration of Sensory Block	6 hours	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.
Time to Ambulation	6 hours	The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Time to Micturation	6 hours	The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States