Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

NCT ID: NCT02862912

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-08
• Study Completion Date: 2020-01-31

Brief Summary

This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

Detailed Description

This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg.

Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as "transient neurologic symptoms" - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours.

Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.

Conditions

Adverse Reaction to Spinal Anesthetic; Maternal Care for Cervical Incompetence

Keywords

Chloroprocaine; cervical cerclage; spinal anesthesia; Bupivacaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Chloroprocaine (CP)

Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)

Group Type: EXPERIMENTAL

Chloroprocaine

Intervention Type: DRUG

Administered as a single injection or continuously through an indwelling catheter - 50 mg

Fentanyl

Intervention Type: DRUG

15 mcg Fentanyl will be included int he spinal anesthetic in both groups

Bupivacaine (BUP)

Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to \~ 2 ml

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)

Fentanyl

Intervention Type: DRUG

15 mcg Fentanyl will be included int he spinal anesthetic in both groups

Saline

Intervention Type: DRUG

Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml

Interventions

Chloroprocaine

Administered as a single injection or continuously through an indwelling catheter - 50 mg

Intervention Type: DRUG

Bupivacaine

A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)

Intervention Type: DRUG

Fentanyl

15 mcg Fentanyl will be included int he spinal anesthetic in both groups

Intervention Type: DRUG

Saline

Preservative free normal saline (0.3 ml) to bring the volume to \~ 2 ml

Intervention Type: DRUG

Other Intervention Names

Nesacaine; Bupivacaine hydrochloride; Sublimaze; Salt water

Eligibility Criteria

Inclusion Criteria

• ASA I and II women
• 18-45 yrs old
• Singleton pregnancy
• Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia
• Height 150 - 180 cm
• BMI ≤ 40 kg/m2.

Exclusion Criteria

• Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy)
• Pre-existing/chronic back pain
• Ester local anesthetic allergy, PABA allergy
• History of atypical cholinesterase (CP is metabolized by cholinesterase)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Richard M. Smiley

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Smiley, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian Hospital

New York, New York, United States

Countries

United States

References

Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Leschka K, Fanelli G. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6. doi: 10.1111/aas.12291. Epub 2014 Mar 6.

Reference Type: BACKGROUND

PMID: 24601887 (View on PubMed)

Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.

Reference Type: BACKGROUND

PMID: 21288208 (View on PubMed)

Lee A, Shatil B, Landau R, Menon P, Smiley R. Intrathecal 2-Chloroprocaine 3% Versus Hyperbaric Bupivacaine 0.75% for Cervical Cerclage: A Double-Blind Randomized Controlled Trial. Anesth Analg. 2022 Mar 1;134(3):624-632. doi: 10.1213/ANE.0000000000005653.

Reference Type: DERIVED

PMID: 34153006 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAQ0916

Identifier Type: -

Identifier Source: org_study_id