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1% Chloroprocaine(PF) vs. Bupivacaine Spinals

NCT03324984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-02-28

Study results available
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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

Interventions

DRUG

1% chloroprocaine

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

DRUG

0.75% bupivacaine

Bupivacaine is used on label

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Elilary Montilla Medrano, MD · Montefiore Medicial Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2023-02-01
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324984 on ClinicalTrials.gov