Skip to main content
OpenTrials
Completed

NCT Number: NCT03305575

Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Incompetence Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pregnancy Complications Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroprocaine

Drug

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 names: Sensorcaine

Bupivacaine

Drug

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 names: Marcaine

Primary outcomes

  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 outcomes

  1. Duration of Sensory Block

    Time frame: 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.

  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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2017
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.