Clinical trial NCT03305575: Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Official title: A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Incompetence
Keywords: Cervical Cerclage
Bupivacaine
Chloroprocaine
spinal anesthesia
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double blinded clinical trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Motor Block
timeFrame: 6 hours
Secondary outcomes:
measure: Duration of Sensory Block
timeFrame: 6 hours
measure: Time to Ambulation
timeFrame: 6 hours
measure: Time to Micturation
timeFrame: 6 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Dan Drzymalski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.
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.
citation: Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.
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. doi: 10.1213/01.ane.0000258766.73612.d8.
citation: 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. doi: 10.1213/01.ane.0000068940.36040.54.