Clinical Trials

Clinical Trial – Heavy Bupivacaine in Peribulbar Block

Most of the ophthalmic procedures are performed under local anesthesia as the patient is
often elderly and with diseases. This may increase the risk of morbidity and mortality under
general anesthesia. Different eye blocks have been practiced with great success. Moreover, it
is associated with less hemodynamic instability, less respiratory depression, better
postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also
associated with a reduction in stress response, maintained oxygen saturation and
cardiovascular stability, in addition to the production of good akinesia and anesthesia
alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe
technique.

Clinical Trial – Acute Postthoracotomy Pain – Impact of Gender

Adequate analgesia in thoracic surgery is essential to prevent severe postoperative
complications, especially respiratory problems. Current knowledge about gender-related
differences in pain states generally more frequent and intense pain and more demand for
analgesics in women. Results about postsurgical pain in particular are very inconclusive.

The investigators tried to find out if gender has an influence on postthoracotomy pain and
analgesics requirement.

Clinical Trial – Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during
lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory
block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine &
IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8
mg nalbuphine compared with (IT) 0.4 mg nalbuphine.

Clinical Trial – Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study

Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and
relatively little data have been published about post-operative maternal pain control in
these settings. Cesarean section is the most common type of major operation at our
institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward
staffing capacity is low, with much basic nursing care provided by families and friends of
patients. The investigators conducted a study to examine the impact of ITM versus TAP block
in a setting of limited formal nursing oversight.

Clinical Trial – Fixed Dose Spinal Bupivacaine for Cesarean Delivery

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.

Clinical Trial – The Effects of Spinal Anesthesia on ED50 and BIS50 of Etomidate for the Loss of Consciousness

The purpose of this study is to investigate the effect of spinal anesthesia on ED50 and BIS50
of etomidate for the loss of consciousness (LOC) by using up-and-down method.The hypothesis
was that spinal anesthesia could significantly reduce the etomidate bolus dose for the LOC
and could also achieve hemodynamic stability during anesthesia induction.

Clinical Trial – Spinal Prilocaine for Caesarian Sections

Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared
to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial
is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both
with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant
larger amount of patients will gain surgical readiness within 8 minutes after spinal
injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical
readiness is defined as a sensory block level of T5 tested by loss of cold sensation.

Clinical Trial – Microlyte Dressing in the Management of Wounds

The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when
used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for
prescription and over the counter use in humans. Primary clinical end point of study is
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or
until wound closure. Patient population comprises patients referred to Mission’s Wound
Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100
subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous
stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20
patients); wounds of various other etiologies (40 patients).

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