Clinical trial NCT03324984: 1% Chloroprocaine(PF) vs. Bupivacaine Spinals
Official title: Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Return of Motor and Sensory Blockade
Anesthesia, Spinal
Decrease Discharge Time Status Post Hemorrhoidectomy
Keywords: Spinal anesthesia
Pain
Chloroprocaine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery Time
timeFrame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
measure: Discharge Time
timeFrame: On post-operative day 1 (POD1), up to 24 hours
Secondary outcomes:
measure: Evidence of Hypotension
timeFrame: On day of procedure, 0-5 minutes following administration of spinal anesthesia
measure: Evidence of Transient Neurological Symptoms (TNS)
timeFrame: On post-op day 2, approximately 24 hours post operation
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medicial Center
name: Elilary Montilla Medrano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420.
citation: Kim SW, Khandaker R, Muse IO, Pulverenti T, Goman M, Patel J, Yedlin A, Balikai CP, Levine R, Choice C, Montilla Medrano E. Comparison of 1% chloroprocaine hydrochloride versus hyperbaric bupivacaine spinal in patients undergoing anorectal surgery in an ambulatory surgery center: a double-blind randomized clinical trial. Reg Anesth Pain Med. 2024 Dec 31:rapm-2024-106130. doi: 10.1136/rapm-2024-106130. Online ahead of print.