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NCT ID: NCT03562793 Not yet recruiting - Pain Clinical Trials

Communication and Activation in Pain to Enhance Relationships and Treat Pain With Equity

COOPERATE
Start date: August 1, 2018
Phase: Early Phase 1
Study type: Interventional

Chronic pain affects approximately 100 million Americans and 40-70% of Veterans, and amounts to over $600 billion/year in direct medical costs and lost worker productivity. Racial disparities in pain care are well-documented, within and outside VA. Minorities are more likely to be undertreated for pain, are subjected to more urine drug tests, and are referred for substance abuse evaluation more frequently than Whites. Minority patients also exhibit lower levels of engagement and active involvement in their healthcare, which leads to poorer communication with providers and poorer outcomes. COOPERATE is a randomized controlled trial testing an intervention to improve minority Veterans' active participation in their pain care by focusing on 2 essential skill sets: 1) goal-setting and prioritization, and 2) communication skills.

NCT ID: NCT03562611 Recruiting - Pain Clinical Trials

Postoperative Pain and Discomfort After Orbital Decompression

Start date: June 8, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.

NCT ID: NCT03562481 Not yet recruiting - Pain Clinical Trials

Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years

Start date: June 8, 2018
Phase: Phase 4
Study type: Interventional

Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children. The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains: 1. Pain experience on injection, time to onset following the administration, and time to recovery [subjective] 2. Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia [objective] Null Hypotheses: 1. No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine. 2. No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations. Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate. One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment. A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.

NCT ID: NCT03554122 Recruiting - Pain Clinical Trials

Efficacy of Shotblocker in Spinal Needle Related Pain

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This was a single-blind, randomized controlled trial. Seventy-six patients who underwent spinal anesthesia for surgery were randomized into the Shotblocker group or Control group. Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.

NCT ID: NCT03553576 Not yet recruiting - Pain Clinical Trials

Drug Concentration and Volume on Adequate Labor Analgesia With PIEB

CADD2
Start date: September 1, 2018
Phase: Phase 4
Study type: Interventional

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. Pain during the first stage of labor is primarily due to lower uterine segment and cervical stretching. The pain signals enter the spinal cord through sensory nerves at the T10 through L1 dermatomes. Pain signals from the late first state and second stage of labor also arise from the vagina and perineum. These signals travel with the pudendal nerve and enter the spinal cord at S2-S4. Thus, 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. The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that PIEB, in combination with PCEA, provide superior maintenance of labor analgesia (less need and longer time to provider intervention, lower local anesthetic consumption, less motor block, and improved patient satisfaction scores) than maintenance with a continuous infusion with PCEA.The mechanism for this difference is not known; however, one suggested mechanism is improved spread of the local anesthetic within the epidural space. Kaynar et al. injected methylene blue dye through a multi-orifice catheter using either a continuous infusion or intermittent bolus and the area of diffusion was measured on a piece of paper. The authors found that intermittent boluses were associated with a greater surface area of diffusion than continuous infusion. In a cadaver study, dye was injected into the lumbar epidural space, and cryomicrotome sections were taken.Dye flowed in rivulets through small channels in the epidural space, as opposed to moving as a unified front. The authors found dye injected at high pressures had more uniform spread through the epidural space, supporting the concept of intermittent epidural injection providing superior analgesia. 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. Recently we completed a double-blinded randomized control trial evaluating two bolus delivery rates, hypothesizing that those patients randomized to receive higher bolus delivery rates would have improved labor analgesia. However, no difference was found between groups.What is more, both groups had a mean cephalad sensory level to cold of T6. This sensory level is higher than the traditional goal of T10 (upper dermatome level of uterine innervation), but despite the adequate sensory level, a large number of patients required supplemental physician-delivered boluses of local anesthetic during labor. Forty percent of the women in the high-rate group and 36% of the low-rate group required a manual re-dose during labor. This suggests that either a higher volume, or higher concentration of local anesthetic (i.e., higher dose) is needed to maintain adequate 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 1.95 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 1.95 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 1.95 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 1.95 mcg/mL).

NCT ID: NCT03551977 Active, not recruiting - Pain Clinical Trials

The Norwegian "iCanCope With Pain" App

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

Background: Research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. Psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. The iCanCope with Pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the Canadian Institutes of Health Research and is based on identified health care needs and current best practices for pain self-management. Objectives: The primary objectives are to describe the translation and cultural adaptation of the Norwegian version of the iCanCope with Pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain. Study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. Recruited from high schools in Southern Norway. Theoretical framework: Cognitive behavioral therapy (CBT) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. The theoretical framework of CBT is integrated in the iCanCope with Pain app in terms of five components. The intervention group will receive the app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education. The control group will receive the app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function. Methods: Both qualitative and quantitative data will be gathered for evaluating the Norwegian version of the iCanCope with Pain app. Usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (RCT). Outcomes will in the RCT be measured at baseline (mid-April) and after an 8 weeks intervention (mid-June). The study is part of a PhD project.

NCT ID: NCT03544619 Enrolling by invitation - Neuropathic Pain Clinical Trials

Reliability and Cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory

Start date: June 10, 2018
Phase:
Study type: Observational [Patient Registry]

In this study, investigators want to perform the reliability and cross-cultural Adaptation of the Turkish Version of the Neuropathic Pain Symptom Inventory

NCT ID: NCT03543085 Recruiting - Pain, Chronic Clinical Trials

Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

Start date: April 12, 2018
Phase: N/A
Study type: Interventional

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.

NCT ID: NCT03541538 Completed - Pain Clinical Trials

Hypoalgesic Effect of Cervical Manipulation

Start date: May 20, 2017
Phase: N/A
Study type: Interventional

This study evaluates the hypoalgesic effect of global and specific cervical joint manipulation in healthy individuals. At first the participants received one of the interventions and after 48 hours, the other.

NCT ID: NCT03538353 Recruiting - Pain Clinical Trials

Patients' Perspectives About a Pain Education Video

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

The overall goal of this single session semi-structured interview project is to explore the validation and contradiction of the preexisting pain beliefs in patients with chronic pain. Aim 1: After patients watch an educational video, explore occurrences of perceived validation and contradiction and the impact of validation and contradiction on pain beliefs, emotion, and pain. Aim 2: Obtain patients' recommendations for improving the educational value of the video.