This is a multicenter, randomized, double-blind, active-controlled study to evaluate the
non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in
lower limbs vascular surgery.
The schedule consists of three visits: screening (visit 1); pre-anesthetic evaluation and
randomization (visit 2); treatment, and discharge from study (visit 3).
The study is designed to compare the effectiveness of spinal anesthesia performed with fixed
dose of hyperbaric bupivacaine regardless of patient’s height and weight and anesthesia with
the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that
spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined
with opioid is very effective, regardless of parturient’s weight and height, provides very
good surgical conditions and assures patient’s comfort while the rate of anesthesia – related
complications is similar or less. Therefore, using height-adjusted protocols, although
preferred in some centres, might not be necessary in order to provide good anaesthesia for
cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric
anesthesia settings, as many of cesareans are performed out of hours, giving less room for
mistakes in less experienced hands.
Two groups of parturients undergoing cesarean section are to be compared: anesthetized with
fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen
(control group). Patients are going to be randomized to one of the above groups, two
anesthetists will be involved in anesthetic procedure: anesthetist that looks after the
patient throughout the procedure will be blinded to the dose of anesthetic given
intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased
and all patients will receive the same perioperative care in terms of fluid therapy,
management of possible anesthesia – related complications and postoperative pain control.
Rate of effective spinal anesthetics, defined as adequate block level and no need for
additional intraoperative analgesia has been established as primary outcome measure.
Secondary outcome measures are rate of complications and amount of opioids used
postoperatively. These are going to be statistically compared.
Pain after transurethral resection of prostate is considered mild to moderate severity from
detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have
been studied including spinal opioids, spinal anesthesia with local anesthetic and
dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with
distilled water irrigation while undergoing a procedure. Most of patients having this
procedure are in elderly period, thus many anesthetists avoided spinal morphine which may
cause respiratory depressant effect postoperatively. Although previous studies showed
effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid
side effects.
The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal
morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to
spinal anesthesia with sole local anesthetic.
The purpose of this study is to investigate whether the addition of a medication called
epinephrine to spinal medications prolongs the duration of the anesthesia. The medication
standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain
medication (morphine). These medications typically last about 2 hours. The investigators want
to determine if adding epinephrine to the spinal medications prolongs the anesthetic without
side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean
section. Epinephrine is known to prolong the action of some local anesthetics, but the
investigators want to specifically study combining it with the medications the investigators
use regularly for cesarean section.
You may qualify to take part in this research study because you are having a repeat cesarean
section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want
to determine if epinephrine will prolong the anesthetic.
The purpose of this study is to investigate whether the dural sac volume as determined by a
geometrical calculation following multilevel measurements of its transverse area and length
by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric
bupivacaine in a non-obstetrical population.