Treatment Trials

73 Clinical Trials for Various Conditions

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WITHDRAWN
Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial
Description

We plan to demonstrate the superiority of epidural anaesthesia/analgesia in repairs of large ventral hernias as compared with a conventional narcotic analgesia regimen. We hypothesize that: 1. Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia. 2. Secondary outcome measures will also improve. Among them will be VAS pain scores, time to first flatus and bowel movement as well as major and minor complications.

Conditions
COMPLETED
Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial
Description

The purpose of this study is to determine if procedural sedation utilizing a 1:1 mixture of propofol and ketamine is equivalent in complications, patient and physician satisfaction, post-procedure pain level, and procedural outcome to propofol sedation alone.

Conditions
RECRUITING
Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients
Description

Rationale: While total knee replacements (TKA) are one of the most commonly performed surgical procedures in the United States, this procedure can also be very painful. Postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. Diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. This will serve as a pilot study for a possible larger controlled trials.

WITHDRAWN
Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
Description

Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous feeding behavior during the first days of life is a significant predictor of long-term breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study, neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when mothers received \>150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean umbilical cord fentanyl concentration was significantly higher in the \>150 mcg versus \<150 mcg group. The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly associated with decreased breastfeeding rates at hospital discharge and with neonatal deficits in latching onto the breast and swallowing during the first three hours of life, and that a significant dose-response relationship exists with respect to total micrograms fentanyl infused. The investigators will perform a prospective cohort study of all parturients age 18+ at UHCMC over a three-month period, excluding those with multiples gestation, Cesarean section, or neonatal intensive care unit admission. From patient charts, the investigators will record the following variables: number of neonates delivered; type of delivery (spontaneous vaginal / operative vaginal / Cesarean section); whether the neonate was admitted to the intensive care unit; the mother's age, height, weight, gravity, parity, intention to breast-feed at the time of hospital admission, number of children previously breast-fed, and ethnicity; gestational age at the time of delivery; administration of oxytocin for labor augmentation and in what quantity; duration of active labor; antibiotic administration; neonatal APGAR scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were administered before and/or after the delivery and at what exact time. We will also record whether each patient received an epidural during labor and, if so, the duration of this epidural infusion and the total micrograms fentanyl delivered; neonatal feeding behavior as quantified by the LATCH scores assigned to each breast-feeding interaction that occurs on the postpartum care floor; whether the mother is breast-feeding her baby at the time of discharge from the hospital, and if not, then her primary reason for not doing so (as communicated during the standard postpartum lactation consultation); and how long mother and baby stayed in the hospital post-delivery.

COMPLETED
Randomized Study Comparing the Use of Epidural Analgesia to Intravenous Narcotics for Laparoscopic Colorectal Resection.
Description

Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various pathology from diverticular disease to colon cancer. In comparison to conventional open surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower wound-related complication rates, better cosmetic results and earlier return to normal activities. Despite the fact that laparoscopic colorectal surgery is done through smaller incisions, there is still a considerable amount of abdominal wall trauma with these procedures. This still can cause a significant amount of postoperative discomfort, which can add to patients' stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can be difficult to control and has been mainly managed pharmacologically with the use of narcotics and non-narcotic medications delivered through different routes. The effectiveness of pain control depends on the medication, its dosage, frequency and route of administration. The latter is mainly achieved through the intravenous route in the immediate postoperative period in laparoscopic colorectal surgery patient, as patients are restricted from having anything by mouth until return of bowel function. Another route of delivery is the use of local anesthetics as well as opioids via an epidural catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia in obstetrics, to date there has been very few studies looking at the effectiveness of epidural analgesia in laparoscopic colorectal surgery. The primary purpose of this study is to evaluate the impact of epidural analgesia as compared to conventional analgesia on the length of hospital stay in patients undergoing laparoscopic colorectal procedures. The secondary objectives of the study will be to evaluate patient satisfaction, quality of life, pain control and return of bowel function in patients treated with either epidural analgesia or intravenous narcotics.

COMPLETED
Evaluation of Changes of Venous Return After Spinal and Epidural Analgesia and Anesthesia by Ultrasound Guided Vena Cava Diameter Measurement
Description

The investigators propose this study to test the hypotheses that inferior vena cava (IVC) diameter can predict hypotension after labor analgesia (epidural, combined spinal-epidural) and neuraxial anesthesia for cesarean section (epidural, combined spinal-epidural and spinal block) in full-term pregnant patients.

TERMINATED
Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base
Description

This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.

Conditions
COMPLETED
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization
Description

This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen. The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.

COMPLETED
Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia
Description

Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.

COMPLETED
Vibration Analgesia in Propofol Infusion During Anesthesia Induction
Description

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Conditions
TERMINATED
Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients
Description

The investigators believe that ultrasound guided CSE technique will help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle via palpation of anatomical landmarks. This will result in increased ability to place the spinal component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor analgesia/anesthesia.

Conditions
COMPLETED
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
Description

We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.

RECRUITING
Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
Description

The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.

RECRUITING
Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Description

The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.

COMPLETED
Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Description

The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.

ENROLLING_BY_INVITATION
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural
Description

As the dural puncture epidural (DPE) is increasing in popularity for labor analgesia, it is important to understand how it impacts outcomes in parturients. Prior studies have found epidural catheters placed via the combined-spinal epidural technique have greater success at surgical conversion for cesarean delivery than catheters placed via traditional techniques. The investigators aim to determine if epidural catheters placed by a DPE technique will also have an increased successful conversion for surgical anesthesia by conducting a retrospective review of all CD during the study period. If an association is found, this could be another benefit of DPE for labor analgesia.

COMPLETED
Neural Correlates of Lidocaine Analgesia
Description

The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.

Conditions
UNKNOWN
Neuroimaging Study of Dexmedetomidine-Induced Analgesia
Description

Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.

COMPLETED
Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
Description

The challenge to achieve adequate analgesia has led to the development of directed, multi-modal protocols specific to management of post-laparoscopy pain in effort to decrease the amount of additional administration of narcotic medication. While several non-opioid regiments have been found to be effective, opioid medications still play a significant role in early postoperative analgesia. Given the adverse side effects of narcotic medications, regional blocks utilizing local anesthetic agents and has been shown to improve overall pain control in this time period. Truncal abdominal nerve blocks are useful for pain control in abdominal and pelvic surgeries. More recently, the utilization of the quadratus lumborum (QL) block has effectively alleviated somatic and visceral pain in the upper and lower abdomen. The QL block provides analgesia spanning from the T4 to L1 dermatomal levels in the thoracolumbar plane to provide a broad sensory level analgesic effect. The approach involves injecting local anesthetic under ultrasound guidance into the plane posterior to the quadratus lumborum muscle and middle layer of thoracolumbar fascia. Given the utility of the QL block in controlling somatic pain, this study aims to determine whether the QL block is an effective analgesic adjunct in the control of postoperative pain period, specifically with regards to patients undergoing laparoscopic gynecologic surgery.

UNKNOWN
Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
Description

The study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.

COMPLETED
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
Description

The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.

COMPLETED
Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption
Description

Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting

Conditions
COMPLETED
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Description

The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.

COMPLETED
Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: Surgeon vs Anesthesia - Ultrasound Guidance
Description

The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.There are many methods to administer local anesthetic into the transversus abdominus plane to provide post-operative analgesia. The more prevalent method is for an anesthesia provider to inject local anesthetic into the plane using ultrasound guidance, before surgery or after the conclusion of surgery. Alternatively, a surgeon can administer the local anesthetic during the operation without additional time or expense using direct laparoscopic visualization. We propose to compare the two methods for non-inferiority, in the context of an established enhanced recovery after surgery (ERAS) program. Non-inferiority being established by no demonstrable difference in post-operative narcotic requirements and equivalent average pain scores.

TERMINATED
Drug Concentration and Volume on Adequate Labor Analgesia With PIEB
Description

Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).

TERMINATED
Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
Description

The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.

COMPLETED
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Description

This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.

COMPLETED
Femoral Nerve Block Versus Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament (ACL) Reconstruction: Evaluation of Post-operative Pain and Strength
Description

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). Post-operatively, the primary outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic analgesic requirements will be measured.

Conditions
COMPLETED
The Effect of a Culturally Sensitive Educational Intervention on Acceptance of Neuraxial Anesthesia
Description

The purpose of this study is to see if an educational intervention provided to pregnant women in early labor has an effect on their decision to use epidural anesthesia for relief of labor pain. The study will also investigate differences between Hispanic and non-Hispanic white women in their attitudes and beliefs regarding epidurals in labor. Previous studies have shown that Hispanic women receive epidural anesthesia in labor much less frequently than their non-Hispanic white counterparts. The investigators hypothesize that the rate of epidural use will be higher in subjects who receive the educational intervention than in those who do not. Women who have been admitted to the OHSU labor and delivery unit will be screened for study eligibility. In order to minimize the influence of socioeconomic factors, only women receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18 years, having a fetus of at least 24 weeks gestational age, and being categorized as American Society of Anesthesiologist category 1 to 3. Exclusion criteria include any condition that either excludes or mandates neuraxial anesthesia. Midwife patients are also excluded from this study. Those who meet study criteria will be approached by a member of the study team and informed consent will be obtained. Subjects will be randomly assigned to receive an educational intervention about epidurals or no educational intervention. Hispanic and non-Hispanic subjects will be randomized separately, yielding four study groups (Hispanic - intervention; Hispanic - control; non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll approximately 176 women, 44 in each group. All subjects will complete a survey in early labor and again 1 to 2 days postpartum that asks about common beliefs and misconceptions regarding epidurals. Subjects in the intervention group will receive an educational pamphlet and watch a video in their native language (spanish or english) about epidurals, and have an opportunity to ask questions. Study staff will collect limited information about the subject's labor and delivery from the electronic medical record.

Conditions
WITHDRAWN
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
Description

The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).