25 Clinical Trials for Various Conditions
This research aims to understand the impact of conditioned open label placebo (COLP) on opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow reduction in opioids taken while maintaining the same level of analgesia.
This study examines the brain activation associated with placebo pain reduction.
Background: - Oxytocin, a substance produced mostly in the brain, plays a role in influencing social interactions and reactions to stress, and may be related to pain. Arginine vasopressin, a hormone that regulates water, sugar, and salt in the blood, influences hostile behaviors and reactions to stress, and may also be related to pain. Researchers are interested in investigating both substances and their relationship to pain in healthy volunteers. Objectives: - To evaluate the effects of oxytocin and arginine vasopressin on pain in healthy volunteers. Eligibility: - Healthy volunteers between 18 and 55 years of age. Design: * This study involves two 2-hour testing sessions held 1 day apart. Each session includes the administration of oxytocin, arginine vasopressin, or placebo (a nonactive substance), or no drug. The drugs and the placebo will be given by a nasal spray. * At the first visit, participants will provide blood and saliva samples to measure hormone levels, and will be asked to fill out questionnaires about some psychological factors such as anxiety and empathy. Participants will then have an assessment of their sensitivity to pain, consisting of a brief electrical stimulation that lasts less than 1 second. After the pain assessment, participants will receive oxytocin, arginine vasopressin, placebo, or no drug at all, and will be monitored to provide baseline information. Participants will then have another pain sensitivity test and will complete the questionnaires again, and provide another saliva sample. * At the second visit, participants will provide another saliva sample; receive oxytocin, arginine vasopressin, placebo, or no drug at all; and have tests of pain sensitivity and a pain-relieving procedure. During the pain-relieving procedure, participants will receive brief, moderately painful electrical shocks on the back of the nondominant hand and a low-level electrical stimulation on the middle finger that counteracts or reduces the pain from the shocks. Participants will rate their pain perception at the end of each stimulation by using a visual scale ranging from 0 (no pain) to 10 (maximum imaginable pain). The experiment ends with a final saliva collection and completion of the psychological questionnaires.
The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium. In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain. Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.
The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. The investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group.
The opioid epidemic is a considerable problem in the United States, and prescription opioids significantly contribute to the epidemic. Head and neck cancer (HNC) patients are inherently at increased risk for opioid dependence as surgical treatment can cause significant pain and up to 50% of patients also suffer from psychiatric comorbidities. Novel methods are needed to decrease opioid consumption following HNC surgeries to limit the risk of chronic opioid dependence in these patients. Conditioning therapy with placebo aims to elicit a classically conditioned response to an inactive medication through consistent pairing of the medication with a neutral stimulus (i.e. an odor) and has been shown to be effective for decreasing the amount of active drug require for certain clinical responses, including for acute pain. However, studies have not been completed for the treatment of acute pain in the inpatient post-operative setting. The overall goal of this pilot study is to determine the feasibility and effectiveness of conditioned open-label placebo (COLP) as an adjunct for post-operative pain management in complex head and neck cancer patients. This randomized, controlled, open-label trial will specifically compare post-operative opioid consumption and pain scales between patients receiving multimodal analgesia along with conditioned open-label placebo (COLP group) to those receiving multimodal analgesia, alone (Treatment as usual group). Findings from this study will determine the efficacy of COLP as an innovative approach to decrease opioid consumption and improve pain control in head and neck cancer patients and will provide rationale for development of future large scale trials.
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.
Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.
Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is called TAP block (transversus abdominis place block). These medications are called local anesthetics, and there is a variety of medications that can be used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the potential benefit of lasting more hours than regular anesthetics. Although this drug is being used with increasing frequency, the investigators do not have good quality studies investigating the benefits of using this medication during a hernia repair, especially when compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to not injecting this medication at all. This study aim to investigate if Exparel®, when injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of additional opioid medications (morphine and similar) needed to achieve good pain control and (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30% decrease in the total requirements for opioid medications during the first 72 hours after surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride, Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP block. All patients will receive a patient controlled analgesia device after the operation, where patients can simply push a button every time they feel pain and the device will administer a dose of opioid medications. The investigators of the study will record the necessary amount of opioids used by the patients to achieve good pain control and also record pain scores several times during hospital stay.
This is a randomized, single-blinded placebo-controlled trial. Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at the end of the operation, (2) injection of standard bupivacaine at the end of the operation, or (3) no injection of local anesthetic. All patients will be able to receive IV and oral narcotic medications in the postoperative period on an as-needed basis. If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement. Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm. Patients who are in the placebo arm will have a similar volume of saline injected into the operative site. Postoperatively, all patients will be kept in the hospital for at least one night. Total length of stay will be documented. They will all have the option of receiving IV morphine injections as well as oral acetaminophen-hydrocodone as needed for additional pain control. The administration of these additional medications will be recorded for each patient. On postoperative day 1, each patient will be administered the American Pain Society Outcome Questionnaire while in the hospital. After discharge from the hospital, we will call the patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the same questions each time. For any patients staying in the hospital longer than 1 day, the questionnaire will be administered in the hospital on the same postoperative days. Subject participation only lasts for these 7 days of follow up.
The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. We were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.
The objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (HSG).
The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo. Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a week over the past 3 months may be eligible for this study. Candidates are screened with a physical examination, x-rays, laboratory and other tests, and questionnaires about pain, mood and medical health. They are given a pain diary to complete for 2 weeks. Participants are admitted to the hospital for two 12 hour overnight stays, during each of which they provide a 24-hour urine collection and have a small blood sample drawn every 20 minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place in a vein. Blood pressure and pulse are monitored during this time. After the catheter is removed, subjects complete questionnaires about their pain, mood and activity. For the several weeks between the two hospitalizations, subjects take either an opioid medication or placebo, or standard medication such as motrin and naprosyn, according to random assignment to one of the three groups. All participants will be allowed to take anti-inflammatory medications and acetaminophen during this time as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary. After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn.
The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.
The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.
The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the board for pain despite a growing recognition of an epidemic of opioid overdose and use disorder. Few solutions have been successfully proposed and implemented. Placebos represent a novel and potentially fruitful means of addressing this issue. However, clinicians often use placebos deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Recently, we reviewed a database of placebo studies including 22 studies in both animals and humans hinting of evidence that placebos may work as a dose extender of active painkillers. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. Here, we will test if dose-extending placebos are effective in relieving clinical acute pain in opioid patients with traumatic pain. Patients will be randomized to three arms. Arm 1 will be a Full Dose (FD) group, which will receive all NSAIDs as described in the Guidelines for NSAID use in Orthopedic Patients and Oxycodone (5mg). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (5mg), and placebos to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebos. Patients will be assigned to one of three arms according to a 1:1:1 schedule of randomization. Study IDs will be generated by the pharmacy and blinding will occur by ensuring that oxycodone and placebos look, smell, and taste identical. Rescue therapy will be provided as needed. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated.
This study examines the mechanisms, including brain imaging of placebo analgesia