A Phase 2 interventional study of 1% chloroprocaine and 0.75% bupivacaine in Return of Motor and Sensory Blockade, Anesthesia, Spinal and Decrease Discharge Time Status Post Hemorrhoidectomy, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Treatment
Among 23 studies in Pain by Montefiore Medical Center — 2 open to participants now, 2 under way, none of them phase 3. Pain · Montefiore Medical Center.
Among the 23 studies in Pain by Montefiore Medical Center, this one is the 16th largest by enrollment, is one of 3 that started in 2019, is one of 6 in phase 2, and was the 18th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 110 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →2 of the 23 studies in Pain by Montefiore Medical Center are open now, in 1 country. Each count lists the studies.
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2019.
Median enrollment 194 across the 23 interventional studies. Of the 21 that completed or were terminated, 18 (86%) have results posted.
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
1 of the studies in Pain by Montefiore Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07048769Montefiore Medical CenterParacervical Block for Pain Reduction in Saline Infusion Sonograms | 2027-07 |
Among the 23 studies in Pain by Montefiore Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
Drug: 1% chloroprocaine
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
Drug: 0.75% bupivacaine
In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
Bupivacaine is used on label
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.
Time frame: 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.
Time frame: On post-operative day 1 (POD1), up to 24 hours
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.
Time frame: On day of procedure, 0-5 minutes following administration of spinal anesthesia
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.
Time frame: On post-op day 2, approximately 24 hours post operation
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.
| Milestone | 1% Chloroprocaine (PF) | 0.75% Bupivacaine |
|---|---|---|
| Started | 55 | 55 |
| Completed | 54 | 51 |
| Not completed | 1 | 4 |
| Withdrew: Inability to place a spinal anesthesia due to the patients' anatomy | 1 | 4 |
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.
| minutes | 1% Chloroprocaine (PF) | 0.75% Bupivacaine |
|---|---|---|
| Recovery Time | 134.1 ± 8.6 | 161.9 ± 10.3 |
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.
| minutes | 1% Chloroprocaine (PF) | 0.75% Bupivacaine |
|---|---|---|
| Discharge Time | 191.4 ± 6.6 | 230.9 ± 9.4 |
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.
| Participants | 1% Chloroprocaine (PF) | 0.75% Bupivacaine |
|---|---|---|
| Evidence of Hypotension | 0 | 0 |
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.
| Participants | 1% Chloroprocaine (PF) | 0.75% Bupivacaine |
|---|---|---|
| Evidence of Transient Neurological Symptoms (TNS) | 0 | 0 |
Collected over Up to 48 hours following procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1% Chloroprocaine (PF) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| 0.75% Bupivacaine | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Mean | 50.5 (45.0 to 58.0) | 48.0 (36.0 to 59.0) | 49.3 (40.6 to 58.5) |
| Sex: Female, Male(Participants) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Female | 19 | 21 | 40 |
| Male | 35 | 30 | 65 |
| Race and Ethnicity Not Collected(Participants) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| United States | 54 | 51 | 105 |
| American Society of Anesthesiologists Physical Status (ASA-PS) Classification(Participants) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Class I | 0 | 4 | 4 |
| Class II | 40 | 37 | 77 |
| Class III | 14 | 10 | 24 |
| Body Mass Index (BMI)(kg/m^2) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Mean | 29.1 (24.4 to 31.7) | 28.1 (24.4 to 32.3) | 28.6 (24.4 to 32.0) |
| Surgical Procedure(Participants) | 1% Chloroprocaine (PF) | 0.75% Bupivacaine | Total |
|---|---|---|---|
| Ablation | 24 | 22 | 46 |
| Anal Fissurectomy | 8 | 5 | 13 |
| Debridement | 6 | 8 | 14 |
| Exam Under Anesthesia | 8 | 3 | 11 |
| Hemorrhoidectomy | 7 | 12 | 19 |
| Other | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Chloroprocaine