Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Cervical Incompetence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305575
• Other study ID #: 12619
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2017
• Est. completion date: August 24, 2018

Study information

• Verified date: August 2020
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Incompetence
• Uterine Cervical Incompetence

Intervention

Drug:
• Chloroprocaine
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.
• Bupivacaine
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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Beilin Y, Zahn J, Abramovitz S, Bernstein HH, Hossain S, Bodian C. Subarachnoid small-dose bupivacaine versus lidocaine for cervical cerclage. Anesth Analg. 2003 Jul;97(1):56-61, table of contents. — View Citation

Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. — View Citation

Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. — View Citation

Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4. — View Citation

Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Ambulation	The time difference between local anesthetic injection and patient's walking for the first time postoperatively.	6 hours
Secondary	Time to Micturation	The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.	6 hours