CompletedPhase 2

1% Chloroprocaine(PF) vs. Bupivacaine Spinals

United States110 participantsStarted 2019-09-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recovery Time

Timeframe: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours

Discharge Time

Timeframe: On post-operative day 1 (POD1), up to 24 hours

Trial details

NCT IDNCT03324984

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

Results submitted2025-02-04