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Opioid Use clinical trials

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NCT ID: NCT05850468 Not yet recruiting - Opioid Use Clinical Trials

Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

Start date: May 2023
Phase: N/A
Study type: Interventional

opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

NCT ID: NCT05611749 Not yet recruiting - Opioid Use Clinical Trials

Duloxetine Impact on Postoperative Pain Control and Outcomes

Start date: November 15, 2022
Phase: Phase 2
Study type: Interventional

1. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative narcotic consumption. 2. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain, function, and quality of life. 3. Evaluate the correlation between preoperative screening tests (measuring pain centralization, anxiety, depression, and overall function) and patients' response to treatment (reduction in pain, anxiety, or depression and improvement in function).

NCT ID: NCT05594459 Not yet recruiting - Opioid Use Clinical Trials

Early Treatment With Invasive Technique in Cancer Pain Management

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Background: high or moderate intensity pain hits more than a half of patients with cancer and is not adequately treated way in 1/3 of this patients. Complexity of cancer pain makes right management difficult and the consequences of an incorrect management are far-reaching in a clinical and social way. A multimodal treatment tailored on the patient, and the evaluation of quality of life correlated to different treatment methodologies, must constitute a decisive element in terms of therapeutic choices. Over the past 30 years, the World Health Organization (WHO) analgesic step ladder has been used to guide the choices management of cancer-related pain, but in the last years the growth of innovative treatment strategies, led to the need to modulate this rigid yet useful system. Benefits would be obtained with interventional techniques (peripheral neural blockade, neuromodulatory device use, neuro-destructive techniques, and intrathecal drug delivery systems) performed in the initial parts of the treatment cycle (before the third step of the WHO scale), rather than applied according to the WHO scale algorithm. Some authors who adopted this approach, reported reduction in pain duration and less opioid consumption, minimizing the risk of opioid related side effects and an improving the overall quality of life . The hypothesis is that early application of interventional techniques in oncological patients has an improving effect in the treatment of chronic cancer pain in terms of efficacy and quality of life. Materials and methods: patients followed by the Cancer Pain Therapy Service of the Cancer National Institute Regina Elena, Rome, with chronic localizable abdominal pain with a value ≥ 7 according to the numeric rating scale (NRS) and a diagnosis of untreatable disease will be randomized into two groups: in the first group patients will be treated with early interventional neuromodulatory techniques, before high opioids dosages. The other group will follow the steps of the WHO scale. Every patient will receive the European Organization for Research and Treatment of Cancer Quality of life-Core 30 Summary Score (EORTC-QLQ C30) survey to detect quality of life and the Numeric rate scale NRS. They will receive it before the treatment, after invasive procedure, one month later and six months later. Primary end point will be the difference of the quality of life questionnaire score between the groups; secondary end point will be difference in the NRS values. The statistic analysis will be based on two groups of patients responding to the including criteria. The sample will be made of 76 patients divided in two sub-sample of equal dimension to select and analyze in 18 months. The sample thus defined is consistent for a confidence interval of 80% and for a margin of error of less than 5%.

NCT ID: NCT05445700 Not yet recruiting - Frailty Clinical Trials

The Effects of Frailty on Opioid Consumption

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Demographic data and intraoperative data of the patients will be recorded. Patients will be transferred to the post-operational post-operative care unit (PACU) and patient-controlled analgesia (PCA) will be applied to each patient with a standard protocol. In the postoperative period, the need for analgesics will be recorded for 24 hours, and if additional analgesics are needed, they will be recorded. Pain scores of the patients will be evaluated for 24 hours.

NCT ID: NCT05437861 Not yet recruiting - Low Back Pain Clinical Trials

Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain?

Start date: August 2022
Phase: N/A
Study type: Interventional

Background Back pain is among the most common cause for sick leave in the working population and is the main cause of years lived with disability globally. In Norway, about 30% report to live with chronic pain and women are affected more than men. Pharmacological strategies for pain management e.g., opioid medications, is a common treatment method. This is despite clinical guidelines suggesting limiting pharmacological treatment in management of chronic back pain. Long-term use of opioids is linked to opioid-induced hyperalgesia, paradoxically. However, it is suggested that RNA sequencing (seq.) profiling may identify individuals that are at risk of opioid-induced hyperalgesia. To help reduce medication intake brief intervention (BI), a method for discontinuing long-term medication use, has shown to be successful. In this pilot RCT the investigators aim to investigate the feasibility of a full scale RCT and observational study using BI on opioid-using patients with back pain and concurrently study if the response can be predicted by RNA seq. Method Ten outpatients aged 18-67 years with back pain will be recruited from the orthopaedic department at Akershus University Hospital. Inclusion criteria includes daily use of opioids for more than two weeks consecutively, and sufficient language (Norwegian) skills. Exclusion criteria includes severe medical or surgical condition such as cauda equina syndrome, rheumatic disease, psychiatric disease, or recent surgery. The patients will be randomised into two groups (5+5) where one group receives the BI and the other gets treatment as usual. Data collection will be conducted at three-time points; baseline, four weeks follow-up and three months follow-up (end of trial). The primary outcome for this pilot RCT is to test feasibility and estimate effect size for a later full-scale study. Secondary outcomes include subjective and objective findings from the data collection. Results Primary results concerning feasibility are mainly qualitative and will be presented as such. Secondary results including demographic information as well as tentative effect size, patient reported outcomes such as pain intensity, anxiety, depression, quality of life, psychosocial stressors in the workplace and the RNA seq will be presented descriptively. Conclusion The results from this pilot study will assist in constructing the optimal design for a full-scale RCT.

NCT ID: NCT05337956 Not yet recruiting - Opioid Use Clinical Trials

Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy

Start date: April 2022
Phase: N/A
Study type: Interventional

Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc. Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The aim of this study is to evaluate the effect of ESPB using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (VATS)

NCT ID: NCT05322564 Not yet recruiting - Surgery Clinical Trials

Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

Start date: May 2022
Phase: N/A
Study type: Interventional

The purpose of this prospective cohort study is to evaluate the opiate prescribing patterns post open reduction and internal fixation (ORIF) of wrist and ankle fractures at the Ottawa Hospital. The primary objective would be to examine the quantity and duration of opiates consumed by the study population, as well as the participant's overall satisfaction with pain control. the investigators will assess whether there is a discrepancy between the quantity of pills prescribed and what is being consumed. With the data collected, the secondary objective would be to create a standardized pain prescription, which the investigators would implement in the second phase of this prospective study. Opiate pills consumed, pain satisfaction and left-over narcotics would again be assessed. The overall goal of this study is to produce an appropriate standardized post-operative prescription, where the number of opiates prescribed mirrors what is being consumed. This would cut down on the quantity of left-over narcotics, helping to reduce the incidence of opiate dependency and diversion in the Ottawa community.

NCT ID: NCT05276089 Not yet recruiting - Opioid Use Clinical Trials

GP Remote Consultation to Reduce Opioid Prescribing

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Opioid prescribing rates are high in the North East and North Cumbria region of England. The COVID-19 pandemic has interrupted the existing regional programme that aims to reduce the use of opioid medications, and also prescribing is likely to have increased during the lockdown. Thus, it has become increasingly challenging for primary care to dedicate sustained clinical time to tackle this complex issue with patients, who may also be reluctant to seek help. A video messaging intervention based upon a GP consultation was developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The short video suitable for smartphone viewing is messaged using a two-way communication system. Patients can watch the video and request additional support by replying with a simple text or email response. This enables efficient delivery of a discrete offer of help to at risk individuals who often avoid service contact. The aim of this study is to evaluate the potential benefits, risks and economic consequences of 'at scale' implementation. This study will be a mixed methods study comprising of a quasi-experimental non-randomised before-and-after study and qualitative interviews. In the first phase, the intervention arm will comprise 50 GP practices in the region using System 1 who will deliver the video to their patients. The control arm comprises 50 practices in the region using EMIS who will continue care as usual. The unit of analysis is the GP practice, with no individual-level quantitative data collected. Monthly practice level data will be accessed and followed up for 6 months. A general linear model will be used to estimate the association between the exposure (video message vs. control) and the outcome (opioid prescribing). In the second phase, semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video and health professionals involved in sending out the videos. These interviews will be audio recorded with participants' consent, transcribed and analysed thematically. As well as evidence and rapid insights to inform the potential accelerated implementation of the intervention within the Integrated Care System, this study will provide evidence that could underpin the future adoption of the intervention into wide scale clinical management that can be disseminated as a future national programme via the Academic Health Science Network.

NCT ID: NCT05256394 Not yet recruiting - Chronic Pain Clinical Trials

Patient-Centered Chronic Pain Care

IPRO
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.

NCT ID: NCT05080348 Not yet recruiting - Pain, Postoperative Clinical Trials

Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair

Start date: December 2021
Phase: N/A
Study type: Interventional

Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).