Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

• ClinicalTrials.gov Identifier: NCT02862912
• Recruitment Status: Completed
• First Posted: August 11, 2016
• Results First Posted: May 26, 2020
• Last Update Posted: December 24, 2020
• Sponsor: Columbia University
• Information provided by (Responsible Party): Richard M. Smiley, Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adverse Reaction to Spinal Anesthetic; Maternal Care for Cervical Incompetence	Drug: Chloroprocaine; Drug: Bupivacaine; Drug: Fentanyl; Drug: Saline	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage
• Actual Study Start Date: November 8, 2016
• Actual Primary Completion Date: January 31, 2020
• Actual Study Completion Date: January 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chloroprocaine (CP); Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)	Drug: Chloroprocaine; Administered as a single injection or continuously through an indwelling catheter - 50 mg; Other Name: Nesacaine; Drug: Fentanyl; 15 mcg Fentanyl will be included int he spinal anesthetic in both groups; Other Name: Sublimaze
Active Comparator: 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	Drug: Bupivacaine; A dextrose Solution is usually given as an injection - 9 mg (1.4 ml); Other Name: Bupivacaine hydrochloride; Drug: Fentanyl; 15 mcg Fentanyl will be included int he spinal anesthetic in both groups; Other Name: Sublimaze; Drug: Saline; Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml; Other Name: Salt water

Outcome Measures

Primary Outcome Measures :

1. Time to Resolution of Motor Block [ Time Frame: 3 hours ]

   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%)

Secondary Outcome Measures :

1. Time to Ambulate [ Time Frame: 5 hours ]
   Time from spinal anesthesia placement to ability to ambulate.
2. Time to Void [ Time Frame: 5 hours ]
   Time from spinal anesthesia injection to ability to void spontaneously.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, New York

New York Presbyterian Hospital

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Richard Smiley, MD; Columbia University

  Study Documents (Full-Text)

Documents provided by Richard M. Smiley, Columbia University:

Informed Consent Form  [PDF] November 13, 2019

Study Protocol and Statistical Analysis Plan  [PDF] November 13, 2019

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Richard M. Smiley, Professor of Anesthesiology, Columbia University
• ClinicalTrials.gov Identifier: NCT02862912
• Other Study ID Numbers: AAAQ0916
• First Posted: August 11, 2016
• Results First Posted: May 26, 2020
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: A research report will be written and submitted to a peer-reviewed journal
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (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.

Keywords provided by Richard M. Smiley, Columbia University:

Chloroprocaine; cervical cerclage; spinal anesthesia; Bupivacaine

Additional relevant MeSH terms:

Uterine Cervical Incompetence; Uterine Cervical Diseases; Uterine Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Fentanyl; Bupivacaine; Chloroprocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General