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Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

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ClinicalTrials.gov Identifier: NCT03305575
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Incompetence Drug: Chloroprocaine Drug: Bupivacaine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double blinded clinical trial.
Masking: Triple (Participant, Investigator, Outcomes 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.

Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : August 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
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.

Other Name: Sensorcaine

Active Comparator: 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).
Drug: 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.

Other Name: Marcaine




Primary Outcome Measures :
  1. Duration of motor block [ Time Frame: 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 :
  1. Duration of sensory block [ Time Frame: 6 hours ]
    The time difference between local anesthetic injection and complete resolution of sensory block.

  2. Time to ambulation [ Time Frame: 6 hours ]
    The time difference between local anesthetic injection and patient's walking for the first time postoperatively.

  3. Time to micturation [ Time Frame: 6 hours ]
    The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305575


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Dan Drzymalski, MD Tufts Medical Center

Publications of Results:
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03305575     History of Changes
Other Study ID Numbers: 12619
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tufts Medical Center:
Cervical Cerclage
Bupivacaine
Chloroprocaine
spinal anesthesia
Additional relevant MeSH terms:
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Uterine Cervical Incompetence
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Bupivacaine
Chloroprocaine
Procaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents