1% Chloroprocaine(PF) vs. Bupivacaine Spinals

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Return of Motor and Sensory Blockade, Anesthesia, Spinal, Decrease Discharge Time Status Post Hemmoriodectomy

Intervention / Treatment
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* Drug: 1% chloroprocaine
* Drug: 0.75% bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing Hemorrhoidectomies Age 18 and above ASA, I-III Exclusion Criteria: Patient refusal Inability to understand and sign 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time | recovery time (return of motor and sensory function) | Up to 100 minutes | 
| discharge time (voiding time) | discharge time (voiding time) | Up to 160 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of hypotension | evidence of hypotension during the case | 0 minutes to 5 minutes of spinal anesthesia | 
| evidence of TNS | evidence of TNS (transient neurologic symptoms) 24hr after procedure. | 24 hours post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal anesthesia, Pain, Chloroprocaine