Clinical Trials

Clinical Trial – Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.

Shivering is very common after spinal anaesthesia. Many studies have investigated the role of
adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal
shivering. Non of the studies n the literature review have investigated the role of different
dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the
present study the investigators aimed to compare the effect of different local anaesthetic
dose in reducing post-spinal shivering.

Clinical Trial – Peripheral Analgesia in Painful Diabetic Neuropathy

Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in
diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that
lead to chronic limb ischemia. Without possible surgical revascularization ,pain management
and tissue healing are used to avoid amputation.

Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a
consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the
inferior limbs, is also increases.

This study compares the efficiency of two analgesic treatments in diabetics with forefoot
injuries.

Clinical Trial – Effects of Analgesics in Cesarean Section Elective

Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean
section.

It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic
(bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to
decrease postoperative pain, but we try to check if one brings more benefit than the other.

Clinical Trial – 1% Chloroprocaine(PF) vs. Bupivacaine Spinals

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.

Clinical Trial – RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.

This is a prospective, randomized, double blind study of 75 patients (n=25 for each group) in
which epinephrine (100mcg or 200mcg) or normal saline vehicle is added to intrathecal
hyperbaric bupivacaine (0.75% bupivacaine hydrochloride in 8.25% dextrose), fentanyl, and
morphine to prolong the duration of the spinal anesthetic in scheduled cesarean deliveries.
The primary outcome of duration will be the time to T10 level sensory regression as well as
motor level regression that will be graded via the modified Bromage scale.

Repeat cesarean sections, in particular, are associated with increased operative time and
thus often performed with a spinal-epidural (CSE) technique. The epidural component is,
however, untested and may not provide adequate anesthesia, thus the higher risk of conversion
to a general anesthesia. Epinephrine is routinely used to prolong spinal anesthesia. If
effective for the duration of a repeat cesarean section it would obviate the additional time
and risks of performing the epidural and still avoid sufficient duration to avoid conversion
to a general anesthetic.

Clinical Trial – Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children

Due its high incidence, mTBI and its consequences of PPCS are a major public health issue.
There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results
in adults, HBOT offers a promising new direction of treatment, which targets the basic
pathological processes responsible for post-concussion symptoms.

The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated.

The aim of the current study is to evaluate in a prospective cross-over, randomized study,
the effect of HBOT on children with PPCS due to mild TBI.

Clinical Trial – Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome

The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as
a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover
clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with
significant improvement in life quality; furthermore, the investigators were able to
demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the
hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.

In the proposed study, the investigators intend to both repeat and expand our previous
findings, treating FMS patients with HBOT while performing an extensive of evaluation both
before and after treatment.

In the current study, the investigators plan to compare HBOT to current standard of care of
FMS (pharmacological and non – pharmacological).

Clinical Trial – Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients

Patients with respiratory disease have an increased risk of developing complications
perioperatively. The use of regional anesthesia decreases this risk with better postoperative
outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal
versus thoracic epidural anesthesia for open nephrectomy in patients with
obstructive/restrictive lung disease.

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