1% Chloroprocaine(PF) vs. Bupivacaine Spinals

February 24, 2025 updated by: Montefiore Medical Center

Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1% Chloroprocaine (PF)
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
Drug: 1% chloroprocaine
In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
Active Comparator: 0.75% bupivacaine
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
Drug: 0.75% bupivacaine
Bupivacaine is used on label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Time
Time Frame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
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
Time Frame: On post-operative day 1 (POD1), up to 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of Hypotension
Time Frame: On day of procedure, 0-5 minutes following administration of spinal anesthesia
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
Evidence of Transient Neurological Symptoms (TNS)
Time Frame: On post-op day 2, approximately 24 hours post operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Elilary Montilla Medrano, MD, Montefiore Medicial Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2019

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-8414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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