Phase 2
N=110
1% Chloroprocaine(PF) vs. Bupivacaine Spinals
Return of Motor and Sensory Blockade · Anesthesia, Spinal · Decrease Discharge Time Status Post Hemorrhoidectomy
Bottom Line
View on ClinicalTrials.gov: NCT03324984 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Recovery Time — 134.1; 161.9 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1% chloroprocaine (Drug); 0.75% bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Time |
134.1; 161.9 | — |
| PRIMARY Discharge Time |
191.4; 230.9 | — |
| SECONDARY Evidence of Hypotension |
0; 0 | — |
| SECONDARY Evidence of Transient Neurological Symptoms (TNS) |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03324984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.