1% Chloroprocaine(PF) vs. Bupivacaine Spinals

NCT ID: NCT03324984

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2023-02-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1% Chloroprocaine (PF)

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

Group Type: EXPERIMENTAL

1% chloroprocaine

Intervention Type: DRUG

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

0.75% bupivacaine

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

Group Type: ACTIVE_COMPARATOR

0.75% bupivacaine

Intervention Type: DRUG

Bupivacaine is used on label

Interventions

1% chloroprocaine

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

Intervention Type: DRUG

0.75% bupivacaine

Bupivacaine is used on label

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elilary Montilla Medrano, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medicial Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-8414

Identifier Type: -

Identifier Source: org_study_id