Clinical Trials

Clinical Trial – The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model

Hyperbaric oxygen may reduce neurophatic pain and promote wound healing. Established anti
inflammatory effects of HBO may contribute to this effect. In a previous publication the
investigators studied the effects of HBO on secondary hyperalgesia using a well established
heat injury model. In a new – blinded study design, the investigators wish to investigate
and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and
improving therapy of severe pain conditions.

Clinical Trial – Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block

The optimal anesthetic technique would provide excellent operating conditions, rapid
recovery, early discharge, no postoperative side effects, and high patient’s satisfaction. In
addition to increasing the quality and decreasing the costs of the anesthetic services (1).
Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific
type of surgery – has become very popular technique) 2(for some orthopedic and gynecological
surgeries [3-9].

Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards
S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries
(11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle
block (11, 12).

Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been
used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has
yet to be determined.

The objective of this study is to determine the minimal effective dose of hyperbaric spinal
bupivacaine required to induce a reliable and satisfactory saddle block for perianal
surgeries (using a modified Dixon’s up-and-down method.

Clinical Trial – Intrathecal Hydromorphone for Labor Analgesia

The objective of this study is to evaluate the effect of intrathecal hydromorphone on the
duration of labor analgesia and the incidence of epidural-associated temperature increase in
laboring parturients. We hypothesize that intrathecal administration of longer-acting
hydromorphone will:

1. Prolong the duration and improve the quality of analgesia in labor, and

2. Decrease the incidence of epidural-associated temperature increase in labor.

Clinical Trial – Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

The cesarean section is considered as a painful surgery during the post operative period.
Mothers may need to move immediately after the surgery to take care of their babies. This may
increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is
required so that mothers do not experience pain in caring for their baby. Currently, several
techniques have been developed to manage postoperative pain related to c-section scar such as
intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound
infiltration. The comparison between anesthetic techniques has never been performed and it is
still not know if the combination of intrathecal morphine plus continuous pre-peritoneal
wound infiltration provide a synergistic or additional effect on pain relief.

Clinical Trial – Delayed Recompression for Decompression Sickness

Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or
tissues during a reduction in environmental pressure (decompression). Bubbles have
mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.
By reducing bubble volume and hastening inert gas elimination, recompression therapy with
hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol
used, is based on US Navy Treatment table 6, started as early as possible after surfacing.
The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the
patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.

The significance of time to recompression is controversial. It has been suggested that early
hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further
tissue injury. However, in recent studies time to recompression had very little effect on
clinical recovery. Moreover, the time beyond which hyperbaric treatment isn’t effective has
not been determined yet.

The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to
divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after
surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early
treatments given at the same hyperbaric unit.

Clinical Trial – The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy

Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non
proliferative DR and proliferative DR. The damage is caused by either macular edema, macular
ischemia that can be followed by vascular proliferation.

Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in
the tissues and has been proven to be beneficial in treating different wounds in diabetic
patients but its effect hasn’t been tested in diabetic retinopathy yet.

This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due
to different indications such as chronic wounds or radiation damages and who also have
diabetic retinopathy. These patients will undergo opthalmic physical examination including
fundus photography and OCT (Optical Coherence Tomography – optical IR retinal photography).
Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe
Medical Center for all diabetic patients prior to their first treatment.

Clinical Trial – Maternal Microcirculation & SDF Imaging

This is a study of pregnant women undergoing a cesarean delivery. It will compare their
microcirculation before and after the anesthetic. Microcirculation means blood flow to the
extremely small blood vessels in the body. It will also look at the differences in
microcirculation of participants who receive an infusion of phenylephrine compared to
participants who don’t. The investigators hypothesize that spinal anesthesia will reduce the
vascular density and proportion of perfused vessels.

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