Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial.
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.
Condition:
Return of Motor and Sensory Blockade
Treatment:
1% chloroprocaine
Start Date:
September 6, 2019
Sponsor:
Montefiore Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT03324984