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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.
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 1% Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 1% Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group. Consents for participation in the study will be obtained during the patients' preoperative anesthesia evaluation. There will be no change in the primary anesthetic technique (spinal anesthesia), since these patients routinely get spinal anesthesia for hemorrhoidectomies, however there would be a change in type of local anesthetic administration. On the day of surgery, consented patients will be randomized to one of the two groups. Both the patients and the researcher who recruited the patients and collected the data will be blinded. (Research assistant will hand an enclosed envelop to the anesthesiologists performing the spinal anesthesia with the name of local anesthetic to use) Postoperatively, the PACU nurse will be ask to document return of motor and sensory function in addition to voiding time. At the time of voiding, the nurse will be asked to inform an anesthesiologist (not involved in the case) for a postoperative evaluation and a discharge note. However, if the patient cannot void once there are able to ambulate, then they stay in PACU until they are the last patient in the unit. If still unable to void, the surgeon will be informed and an ultrasound bladder scan will be used to determine the volume of urine and the patient will be straight cath. The patient will be sent home and informed if he or she cannot void by the next day, then they should call the surgeon's office to notify them and go to the emergency room.
For postoperative data collection, the routine 24hr postoperative phone calls in which nurses make to patients will be utilize, however two additional questions will be asked, 1. Presence of nerve pain in the buttocks and thighs shooting down their legs unilaterally or bilaterally, 2. Inability to void, pass flatus or defecate. If any of the symptoms are present, then the nurse will inform an anesthesiologist (not involved in the case) whom will give the patient a call and advise them on treatment protocol. The research assistant will then be informed by the anesthesiologist who made the phone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Chloroprocaine (PF) | Experimental | 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% chloroprocaine | Drug | In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Hypotension | Evidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm. | On day of procedure, 0-5 minutes following administration of spinal anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elilary Montilla Medrano, MD | Montefiore Medicial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12131105 | Background | 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. | |
| 16301234 | 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. |
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Between September 2019 and February 2023, a total of 110 eligible patients were randomized and 55 were assigned to each treatment group, 1% Chloroprocaine or 0.75% Bupivacaine. Study was paused from March 2020 to September 2020 due to the pandemic and was also paused December 2020 because the surgery center was closed and the pharmacy was unable to obtain the necessary medications from the manufacturer.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Chloroprocaine (PF) | 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. 1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. |
| FG001 | 0.75% Bupivacaine | 0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose. 0.75% bupivacaine: Bupivacaine is used on label |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Chloroprocaine (PF) | 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. 1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. |
| BG001 | 0.75% Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | minutes | On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours |
|
Up to 48 hours following procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Chloroprocaine (PF) | 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. 1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elilary Montilla Medrano | Montefiore Medical Center | 929-263-3302 | emontill@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2019 | Jan 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2022 | Jan 10, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
| 0.75% bupivacaine | Drug | Bupivacaine is used on label |
|
| Evidence of Transient Neurological Symptoms (TNS) | The number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm. | On post-op day 2, approximately 24 hours post operation |
| 25211156 | 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. |
| 12430108 | 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. |
| 24189768 | 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. |
| 14693591 | 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. |
| 14693593 | 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. |
| 14693590 | 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. |
| 15673893 | 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. |
| 21288208 | 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. |
| 10422927 | 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. |
| 19934900 | 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. |
| 21203878 | 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. |
| 27281722 | 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. |
| 39740957 | Result | 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. 2026 Mar 5;51(3):324-329. doi: 10.1136/rapm-2024-106130. |
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose. 0.75% bupivacaine: Bupivacaine is used on label |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists Physical Status (ASA-PS) Classification | Patients physical status at baseline was recorded using the American Society of Anesthesiologists Physical Status (ASA-PS) classification. Healthy patients with no significant systemic disease were classified as Class I. Patients with mild systemic disease that did not significantly limit daily activities were classified as Class II. Patients with severe systemic disease that limited daily activities were classified as Class III. Results have been summarized by study arm. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI data was collected at baseline and summarized by study arm. | Mean | Inter-Quartile Range | kg/m^2 |
|
| Surgical Procedure | The type of anorectal procedure performed is summarized by study arm. | Count of Participants | Participants |
|
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
| OG001 | 0.75% Bupivacaine | 0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose. 0.75% bupivacaine: Bupivacaine is used on label |
|
|
| Primary | 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. | Posted | Mean | Standard Error | minutes | On post-operative day 1 (POD1), up to 24 hours |
|
|
|
| Secondary | Evidence of Hypotension | Evidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm. | Posted | Count of Participants | Participants | On day of procedure, 0-5 minutes following administration of spinal anesthesia |
|
|
|
| Secondary | Evidence of Transient Neurological Symptoms (TNS) | The number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm. | Posted | Count of Participants | Participants | On post-op day 2, approximately 24 hours post operation |
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| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 0.75% Bupivacaine | 0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose. 0.75% bupivacaine: Bupivacaine is used on label | 0 | 51 | 0 | 51 | 0 | 51 |
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| D000588 |
| Amines |