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Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Primary Purpose

Cervical Incompetence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chloroprocaine
Bupivacaine
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Incompetence focused on measuring Cervical Cerclage, Bupivacaine, Chloroprocaine, spinal anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chloroprocaine

Bupivacaine

Arm 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)

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Time to Ambulation
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Time to Micturation
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.

Full Information

First Posted
October 4, 2017
Last Updated
August 16, 2020
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03305575
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Incompetence
Keywords
Cervical Cerclage, Bupivacaine, Chloroprocaine, spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blinded clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient. Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloroprocaine
Arm Type
Experimental
Arm 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)
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Chloroprocaine
Other Intervention Name(s)
Sensorcaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of Motor Block
Description
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
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Duration of Sensory Block
Description
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 Frame
6 hours
Title
Time to Ambulation
Description
The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
Time Frame
6 hours
Title
Time to Micturation
Description
The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6705717
Citation
Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.
Results Reference
background
PubMed Identifier
21203878
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.
Results Reference
background
PubMed Identifier
15673895
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.
Results Reference
background
PubMed Identifier
17377114
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.
Results Reference
background
PubMed Identifier
12818944
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.
Results Reference
background

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Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

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