Treatment Trials

103 Clinical Trials for Various Conditions

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COMPLETED
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Description

The objective of this study will be to compare epidural infusion management, specifically looking at infusion rate changes, in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as well as parity, in order to eliminate these variables as potential con-founders. We hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery.

COMPLETED
Neuraxial Ultrasound for Thoracic Epidural Placement
Description

This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.

COMPLETED
Ultrasound Determination of Needle Depth in Epidurals in Adult Patients
Description

The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement. The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.

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.

UNKNOWN
Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
Description

Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter. Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal. This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.

Conditions
RECRUITING
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Description

This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. Epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy.

COMPLETED
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Description

The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.

WITHDRAWN
Goal-directed Labor Epidural Analgesia Maintenance
Description

The GLEAM trial is a multicenter, pragmatic, cluster-randomized trial to assess the effects of programmed intermittent epidural bolus versus continuous epidural infusion on the rate of spontaneous vaginal delivery and several other clinically-relevant outcomes.

WITHDRAWN
Effect of Epidural Analgesia During Labor on Force of Maternal Push
Description

There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions. The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.

COMPLETED
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Description

The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h

COMPLETED
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Description

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

Conditions
COMPLETED
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
Description

The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.

UNKNOWN
Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
Description

There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo \& Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002). We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.

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
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
Description

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).

COMPLETED
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Description

This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment. The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.

COMPLETED
Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Description

Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

Conditions
RECRUITING
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
Description

This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients undergoing liver surgery. It is not yet known whether thoracic epidural analgesia or four-quadrant transversus abdominus plane block may help people to recover more completely and more quickly after surgery.

COMPLETED
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Description

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

UNKNOWN
Sleep Efficiency and Quantification After Labor Epidural Analgesia
Description

The specific aim is to attempt to quantify the amount and efficiency of sleep that parturients receive after placement of labor epidural analgesia.

Conditions
COMPLETED
The Prevention of Hypotension After Epidural Analgesia After Major Surgery
Description

Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely and very successfully used routinely for perioperative pain control in patients undergoing major orthopedic and abdominal surgery since 1928. The choice currently depends on the preference of the APS physician in charge of the case. A frequent unwanted side effect of epidural block is hypotension due to the epidurally injected LA blocking the sympathetic nerves and thus the patient's response to hypotension, which is usually due to hypovolemia and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this research study is to see if adding epinephrine, to the epidural anesthetic will decrease possible side effects, such as low blood pressure, and lead to a better effect of the epidural anesthetic.

Conditions
COMPLETED
Epidural Analgesia Use in Pancreatic Resections
Description

The rationale for this study is to investigate the benefits of epidural analgesia in pancreatic resections in a prospective, single blind, randomized control trial. This study will evaluate both short and long-term outcomes related to epidural analgesia, providing a longitudinal and comprehensive perspective to the advantages and disadvantages of this technique. The investigators hypothesize that the use of epidural analgesia reduces a patient's consumption of morphine or morphine-equivalent in the post-operative period following pancreatic resections.

TERMINATED
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
Description

Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.

Conditions
ACTIVE_NOT_RECRUITING
Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection
Description

The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.

COMPLETED
Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants
Description

This a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.

Conditions
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.

TERMINATED
A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excavatum Repair
Description

The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain score during postoperative days 0-4.

TERMINATED
Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Description

1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia. Hypothesis: The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

COMPLETED
Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
Description

The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery

Conditions
UNKNOWN
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
Description

This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA).