Clinical Trials

Clinical Trial – Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It
disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and
the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator,
ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle
but, rarely reaches the lumbar plexus.

The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of
resistance technique. Feeling two tactile ”pops” due to loss of resistance occurred during
the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of
FIB will increase the success rate and the efficacy of sensory blockade by decreasing the
needed local anesthetic amount.

Clinical Trial – ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation

Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral
tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial
anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be
injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication
shortages have resulted in limited availability on a local and national level. One proposed
alternative is isobaric bupivacaine; however, studies investigating its use for post-partum
bilateral tubal ligation are limited.

The purpose of this prospective study is to determine the minimal effective dose (ED50 and
ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after
vaginal delivery.

Clinical Trial – Hyperbaric Oxygen Therapy Effects on Pulmonary Functions

Prospective analysis included patients, 18 years or older, scheduled for 60 daily HBOT
sessions between 2016-2018. Each session was 90 min of 100% oxygen at 2 ATA with 5 minutes
air breaks every 20 min, five days per week. Pulmonary functions,measured at baseline and
after HBOT,included forced vital capacity (FVC), forced expiratory volume in one second
(FEV1), peak expiratory flow rate (PEF).

Clinical Trial – Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia

Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic
musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders,
morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms
are back pain, headaches, irritable bowel, balance problems and deterioration of physical
function in general. Patients with fibromyalgia (FM) often show pain at specific points that
are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli"
(hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the
physical examination and in the absence of anomalies that justify in the biological or image
tests. These pain points to pressure, based on the most specific and specific criteria for
the diagnosis of the disease, traditionally based on the criteria of the American College of
Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful
points to confirm it. Although the etiology remains unknown and unclear, its appearance is
attributed to a problem of central sensitization, that is, changes in central processing,
which causes an alteration of the mechanisms that regulate the sensation of pain, with
amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is
becoming a common syndrome in the countries of Western Europe, with a prevalence in the
general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In
addition, it has a higher incidence in women than men (73-95%), predominantly affecting women
between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when
menopause occurs, so not only do they experience the symptoms of both states but they even
exacerbate the syndrome with each other. On the other hand, and in relation to its
chronicity, the care of this type of patients involves large costs for society with a
significant consumption of health resources in the field of primary care, as well as the
costs of work absenteeism. For these reasons, it is considered an important problem with a
great impact on the health system, and therefore more and more studies are being developed
with the aim of better understanding the pathophysiology of this disease. The therapeutic
approach includes low cost and easy access measures, such as physical exercise (EF) programs
to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint
and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on
cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise,
performed between 60% and 70% of the maximum heart rate two to three times a week. However,
to date, there is no study that compares the effectiveness of physical exercise with other
innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the
hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of
patients with fibromyalgia. The general objective is the effectiveness of transcranial
magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific
objectives we propose:

To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia.

– Object the effect of HBOT, TMS and EF in cortical functioning.

– Evaluate the effect of HBOT, TMS and EF on fatigue.

– Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and
anxiety.

– Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of
painful points.

– Evaluate the effect of HBOT, TMS and EF on the quality of sleep.

– Evaluate the effect of HBOT, TMS and EF on the quality of life.

– Evaluate the effect of HBOT, TMS and EF on the pain constructs.

– Determine the effect of HBOT, TMS and EF on plasma endorphin levels.

Clinical Trial – A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or
lymph glands. The UCB transplant has advantages over other types of transplants such as ease
of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious
infections, and the availability for immediate use. The UCB transplant is also associated
with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft
attacks the recipient organs).

Clinical Trial – Spinal Anesthesia in Caesarean Section

Spinal anesthesia is a safe technique, widely used and tested in the gynecological field, so
as to be considered the first choice technique in cesarean section, which allows to quickly
obtain a valid sensor and motor block. Bupivacaine is one of the most widely used drug for
obtaining spinal anesthesia in pregnant women undergoing caesarean section. Bupivacaine is a
local anesthetic available as a racemic mixture of its two enantiomers, the R (+)-
dextrobupivacaine and the S (-) – levobupivacaine, whose clinical use is widely validated.
Racemic bupivacaine is available as a simple or hyperbaric solution, the latter being the
most commonly used for spinal anesthesia. Levobupivacaine, which is the pure levorotatory
enantiomer of racemic bupivacaine, is a slightly hypobaric solution compared to liquor and
has shown less heart and nerve toxicity, probably due to its ability to bind proteins more
rapidly, and a greater selectivity towards the sensory component compared to Bupivacaine,
presents action and effects better predictable. Its baricity would also offer the advantage
of providing a less sensitive block to the position.

Hypotension is one of the most common complications of spinal anesthesia and is particularly
relevant in caesarean section because, in addition to the adverse effects on the parturient,
it can have repercussions on the fetus through a reduction of placental perfusion.

Some studies have showed a similar incidence of hypotension in patients treated with
bupivacaine compared to those treated with levobupivacaine, while others assert an
equivalence between the two drugs. In most studies, however, a significantly lower incidence
of hypotension and a greater hemodynamic stability were reported in pregnant patients
undergoing spinal anesthesia by caesarean section with levobupivacaine.

Being both hyperbaric bupivacaine and levobupivacaine routinely used at the "G. Rodolico"
Universitary Hospital of Catania for the spinal anesthesia of pregnant women undergoing
caesarean section and being their use decided exclusively at discretion of the treating
anesthesiologist, in the light of the discrepant data in the literature about the incidence
of hypotension with the two drugs, the main objective of this observational study is to
evaluate the hemodynamic effects mediated by levobupivacaine on pregnant women subjected to
elective cesarean section and to compare them with those mediated by hyperbaric bupivacaine
in an historical court of pregnant women subjected to caesarean section in the period between
April 2017 and April 2018. The hemodynamic parameters will be monitored in real time with a
non-invasive hemodynamic monitoring system (EV1000® platform + Clearsight® system – Edwards
LifeSciences), routinely used in the "G. Rodolico" Universitary Hospital of Catania, allowing
to obtain greater accuracy and veracity of the results compared to previous studies conducted
on such anesthetics.

Clinical Trial – Spinal Anesthesia For Enhanced Recovery After Liver Surgery

This project proposes to compare epidural versus spinal anesthesia in patients having liver
resection surgery. The investigators hypothesize that spinal anesthesia will result in
improved blood pressure control postoperatively and reduce the amount of intravenous fluids
required after surgery. Spinal anesthesia is expected to provide the same pain control
benefits as epidurals, with faster recovery of function. Spinal anesthesia may be a simple
and effective way to improve and enhance the recovery in the increasing number of patients
requiring liver resection.

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