Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

NCT02862912 | Completed Phase 4 Results

• 1 other identifier: AAAQ0916
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Reaction to Spinal Anesthetic; Maternal Care for Cervical Incompetence

Keywords

Chloroprocaine; cervical cerclage; spinal anesthesia; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Motor Block

  The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)

  3 hours

Secondary Outcomes (2)

• Time to Ambulate

  5 hours

• Time to Void

  5 hours

Study Arms (2)

Chloroprocaine (CP)

EXPERIMENTAL

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

Drug: Chloroprocaine; Drug: Fentanyl

Bupivacaine (BUP)

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Drug: Fentanyl; Drug: Saline

Interventions

Chloroprocaine DRUG

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

Also known as: Nesacaine

Chloroprocaine (CP)

Bupivacaine DRUG

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

Also known as: Bupivacaine hydrochloride

Bupivacaine (BUP)

Fentanyl DRUG

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

Also known as: Sublimaze

Bupivacaine (BUP); Chloroprocaine (CP)

Saline DRUG

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

Also known as: Salt water

Bupivacaine (BUP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 24601887 BACKGROUND

• 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.

  PMID: 21288208 BACKGROUND

• 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.

  PMID: 34153006 DERIVED

MeSH Terms

Interventions

chloroprocaine; Bupivacaine; Fentanyl; Sodium Chloride; Fluoridation

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Limitations and Caveats

Despite low dropout risk, we proposed to enroll an additional 4 subjects/group above calculated sample size. The significantly shorter discharge times among some subjects became increasingly apparent. It became untenable to claim clinical equipoise. After the originally calculated sample size was achieved, we decided to stop enrolling new cases, accounting for uneven group numbers. A Shapiro-Wilk test indicated block resolution and discharge time data was non-normal (medians \[IQR\] reported).

Results Point of Contact

• Title: Dr. Allison Lee
• Organization: Columbia University

al3196@cumc.columbia.edu

212-305-6494

Study Officials

• Richard Smiley, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: November 8, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 24, 2020
• Results First Posted: May 26, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Submission will be made by December, 2020. Publication availability is to be determined by the peer review process. Once published, the data should be available indefinitely.
• Access Criteria: To be determined.

Locations

US (1)