1% Chloroprocaine(PF) vs. Bupivacaine Spinals

NCT03324984 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017-8414
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 2-Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 2-Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group.

Conditions

Return of Motor and Sensory Blockade; Anesthesia, Spinal; Decrease Discharge Time Status Post Hemorrhoidectomy

Keywords

Spinal anesthesia; Pain; Chloroprocaine

Outcome Measures

Primary Outcomes (2)

• Recovery Time

  For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.

  On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours

• Discharge Time

  For this study discharge time is defined as the time (in minutes) when the patient is "fit to discharge" from the Postoperative Care Unit (PACU). At the institution where this study took place "fit to discharge" was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal.

  On post-operative day 1 (POD1), up to 24 hours

Secondary Outcomes (2)

• Evidence of Hypotension

  On day of procedure, 0-5 minutes following administration of spinal anesthesia

• Evidence of Transient Neurological Symptoms (TNS)

  On post-op day 2, approximately 24 hours post operation

Study Arms (2)

1% Chloroprocaine (PF)

EXPERIMENTAL

1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.

Drug: 1% chloroprocaine

0.75% bupivacaine

ACTIVE COMPARATOR

0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.

Drug: 0.75% bupivacaine

Interventions

1% chloroprocaine DRUG

In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.

1% Chloroprocaine (PF)

0.75% bupivacaine DRUG

Bupivacaine is used on label

0.75% bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing anorectal procedures
• Age 18 and above
• American Society of Anesthesiologist Physical Status (ASA), I-III

You may not qualify if:

• Patient refusal
• Inability to understand and sign informed consent
• Allergic reaction to bupivacaine or other local anesthetics
• Coagulopathy (INR \>= 1.5)
• Use of anticoagulant drugs (Plavix, Coumadin)
• Thrombocytopenia (Platelets \< 100,000)
• Infection at the site
• Increased intracranial pressure
• Unstable spine, Spine abnormalities
• History of atypical cholinesterase (CP is metabolized by cholinesterase)
• Diagnosis of any disorders (i.e., benign prostatic hyperplasia, cystitis, vulvovaginitis) that would delay voiding
• Anticipated procedure time longer than 60 minutes

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (15)

• Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.

  PMID: 12131105 BACKGROUND

• Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.

  PMID: 16301234 BACKGROUND

• Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.

  PMID: 25211156 BACKGROUND

• Pollock JE. Transient neurologic symptoms: etiology, risk factors, and management. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):581-6. doi: 10.1053/rapm.2002.36457. No abstract available.

  PMID: 12430108 BACKGROUND

• Fanelli A, Ghisi D, Allegri M. Is spinal anaesthesia a suitable technique for ultra-short outpatient procedures? Acta Biomed. 2013 Jun 1;84(1):76-80.

  PMID: 24189768 BACKGROUND

• Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine. Anesth Analg. 2004 Jan;98(1):81-88. doi: 10.1213/01.ANE.0000093361.48458.6E.

  PMID: 14693591 BACKGROUND

• Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 2004 Jan;98(1):89-94. doi: 10.1213/01.ANE.0000093360.02058.ED.

  PMID: 14693593 BACKGROUND

• Kouri ME, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth Analg. 2004 Jan;98(1):75-80. doi: 10.1213/01.ANE.0000093228.61443.EE.

  PMID: 14693590 BACKGROUND

• Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth Analg. 2005 Feb;100(2):553-558. doi: 10.1213/01.ANE.0000130397.38849.4A.

  PMID: 15673893 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

• Pavlin DJ, Pavlin EG, Fitzgibbon DR, Koerschgen ME, Plitt TM. Management of bladder function after outpatient surgery. Anesthesiology. 1999 Jul;91(1):42-50. doi: 10.1097/00000542-199907000-00010.

  PMID: 10422927 BACKGROUND

• Mulroy MF. Outpatients do not need to void after short neuraxial blocks. Anesthesiology. 2009 Dec;111(6):1388; author reply 1389. doi: 10.1097/ALN.0b013e3181bfa8d3. No abstract available.

  PMID: 19934900 BACKGROUND

• Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.

  PMID: 21203878 BACKGROUND

• Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420.

  PMID: 27281722 BACKGROUND

• Kim SW, Khandaker R, Muse IO, Pulverenti T, Goman M, Patel J, Yedlin A, Balikai CP, Levine R, Choice C, Montilla Medrano E. Comparison of 1% chloroprocaine hydrochloride versus hyperbaric bupivacaine spinal in patients undergoing anorectal surgery in an ambulatory surgery center: a double-blind randomized clinical trial. Reg Anesth Pain Med. 2024 Dec 31:rapm-2024-106130. doi: 10.1136/rapm-2024-106130. Online ahead of print.

  PMID: 39740957 RESULT

MeSH Terms

Conditions

Pain

Interventions

chloroprocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Elilary Montilla Medrano
• Organization: Montefiore Medical Center

emontill@montefiore.org

929-263-3302

Study Officials

• Elilary Montilla Medrano, MD

  Montefiore Medicial Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patients, the researcher who recruited the patients and collected the data, nurse anesthetists, discharge anesthesiologist, and the Post Anesthesia Care Unit (PACU) nurse were all blinded to the patient treatment allocations. The operating room anesthesiologist (separate from the discharge anesthesiologist) was unblinded after receiving an enclosed envelope with the name of the spinal local anesthetic to perform the neuraxial anesthesia intraoperatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: September 11, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)