Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

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Tufts University

Status and phase

Completed
Phase 4

Conditions

Cervical Incompetence

Treatments

Drug: Chloroprocaine
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03305575
12619

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

10 participants in 2 patient groups

Chloroprocaine
Experimental group
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)
Treatment:
Drug: Chloroprocaine
Bupivacaine
Active Comparator group
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).
Treatment:
Drug: Bupivacaine

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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