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Acute Pain clinical trials

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NCT ID: NCT05152602 Completed - Regional Anesthesia Clinical Trials

Comparation of Bilateral and Unilateral Erector Spinae Plane Block

Start date: January 1, 2022
Phase:
Study type: Observational

Although laparoscopic cholecystectomy is a minimally invasive surgery with many advantages, it is one of the operations with high postoperative pain scores. Opioids are frequently used to prevent postoperative pain. Due to the side effects of opioids, the amount of use is tried to be reduced. Regional anesthesia techniques can be used to minimize opioid consumption. Erector spina plane block was first described in 2016 by Forero et al. in the treatment of thoracic neuropathic pain. Since then, ESP block has been used as an anesthetic and analgesic technique. It is applied by injecting local anesthetic into the fascial plane located between the erector spina muscle and the transverse process of the vertebra. Several high-level studies have shown that the ESP block can be used to reduce postoperative pain after gastrointestinal surgery. Several studies have evaluated the effect of ESP block for pain relief after laparoscopic cholecystectomy. ESP block has been applied unilaterally or bilaterally in various studies. However, in the current studies in the literature, the advantages or disadvantages of the bilateral application of the ESP block compared to the unilateral application have not been evaluated. In this study, the investigators aimed to evaluate postoperative pain by applying ESP block to patients who underwent laparoscopic cholecystectomy and to evaluate the advantages of unilateral or bilateral application of ESP block over each other.

NCT ID: NCT05150795 Recruiting - Clinical trials for Post Operative Pain, Acute

Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Start date: January 1, 2022
Phase: Early Phase 1
Study type: Interventional

Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state. Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness. Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.

NCT ID: NCT05147714 Completed - Analgesia Clinical Trials

The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia Consumption

Start date: January 1, 2019
Phase:
Study type: Observational

Postoperative pain management has an important role in anesthesia practice. In order to ensure postoperative patient comfort, postoperative rehabilitation should start early and be managed effectively1. It is known that if adequate analgesia is not provided before the patient wakes up, the severity of pain and the total opioid consumption increases. This increased opioid use causes complications such as nausea, vomiting, constipation, increased sleepiness and respiratory depression2. For this reason, the provision of adequate analgesia before the patient is awakened from general anesthesia has an important place in the process. Measurement of pain has different characteristics in patients under sedation or general anesthesia compared to conscious patients. However, since it is not possible for the patient to define pain under general anesthesia, different measurement and evaluation methods are needed. In order to monitor the intraoperative balance between nociception and antinociception, several non-invasive methods with different physiological approaches have been researched and made available for use in the last decade. The aim of these methods is individualize the intraoperative and postoperative opioid dose3. In this context, it has been suggested that the Surgical Pleth Index (SPI) method can be used in the evaluation of the analgesic component of anesthesia.

NCT ID: NCT05145153 Recruiting - Postoperative Pain Clinical Trials

Incidence of Chronic Pain After Thoracic Surgery

Start date: September 28, 2021
Phase:
Study type: Observational

Thoracotomy and video-assisted thoracic surgery procedures are frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. This prolongs the discharge time of the patients, and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. Video-assisted thoracic surgery (VATS) has become the standard procedure in minor and major lung surgeries. Postoperative pain is seen in patients undergoing VATS, although it is not as severe as after thoracotomy. As in thoracotomy, this affects the postoperative pulmonary complications and the discharge time of the patients. Likewise, this pain can cause chronic pain. In this study, it was aimed to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracic surgery.

NCT ID: NCT05137184 Completed - Acute Pain Clinical Trials

A Comparison of Three Regimens of Acute Pain Management: Methoxyflurane; Intranasal Fentanyl; Intravenous Morphine

PreMeFen
Start date: November 12, 2021
Phase: Phase 3
Study type: Interventional

The study rationale is to provide evidence for early, safe and effective pain management in the ambulance service with non-invasive and fast acting analgesics. Low-dose methoxyflurane and intranasal fentanyl are non-invasive medications that are well-suited for use by ambulance personnel under difficult pre-hospital settings. This is a randomized, controlled, open label, three-arm, non-inferiority, phase 3 drug trial performed in the ambulance service. The randomization will be 1:1:1 to the three treatment groups. Patients 18 years or older with acute pain with Numeric Rating Scale (NRS) ≥4 with normal physiology and capable of giving informed consent will be included null hypothesis (H0) (tested in hierarchic order a-b-c): 1. Methoxyflurane regimen is inferior to intranasal fentanyl regimen or 2. Methoxyflurane regimen is inferior to IV morphine regimen or 3. Intranasal fentanyl regimen is inferior to IV morphine regimen for treating moderate to severe pain, measured by reduction in Numeric Rating Scale (NRS) 10 minutes after administration. The study duration for each participant will be from ambulance scene arrival to patient handover in emergency department. Number of participants: Patient enrolment until successful inclusion of 270 per protocol patients. Primary endpoint is change in NRS from before administration (t0) to 10 minutes after start of administration (t10). The study intervention is one of the three IMPs: - Methoxyflurane: 3 ml inhalation, can be repeated once to a total dose of 6 ml. - Fentanyl intranasal spray: 100 µg IntraNasal, (patients >70 years 50 µg), can be repeated to maximum total dose 500 µg IN. - Morphine hydrochloride intravenous: 0.1 mg/kg IV (patients >70 years or fragile 0.05 mg/kg IV), can be repeated to a maximum total dose 0.5 mg/kg IV. Rescue analgesia is all analgesics other than the allocated IMP. If rescue medication is administered before the assessment of primary endpoint at 10 minutes, the patient will not be part of the per-protocol analysis. The hypothesis will be tested and the primary endpoint will be evaluated by the 95% confidence limits (95% CI), and a conclusion of non-inferiority will be made if the 95% CI of the estimated treatment difference fully lie within the inferiority margin. Non-inferiority is determined on the basis of a 1-sided equivalence t test on the per protocol population and confirmed, for sensitivity reasons, on the modified intention to treat population.

NCT ID: NCT05130307 Completed - Pain, Acute Clinical Trials

Virtual Reality Analgesia for Brief Thermal Pain

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

Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.

NCT ID: NCT05118620 Withdrawn - Pain, Postoperative Clinical Trials

Pericapsular Nerve Group Block (PENG) for Hip Surgery

Start date: December 9, 2021
Phase: Phase 4
Study type: Interventional

This will be a randomized comparison of pericapsular nerve group (PENG) blocks with bupivacaine and a placebo control (PENG blocks with normal saline). The overall objective of the proposed research is to determine the relative risks and benefits of a single-injection PENG block to provide postoperative analgesia following hip arthroscopy. Hypothesis 1: Following hip arthroscopy, participants with a PENG block will experience less pain in the recovery room compared with current standard-of-care as measured with the Numeric Rating Scale (NRS). Hypothesis 2: Following hip arthroscopy, participants with a PENG block will consume less opioid in the operating and recovery rooms compared with current standard-of-care as measured in oral morphine milligram equivalents. Primary end point: In order to claim that PENG blocks are superior to placebo overall, at least one of these two hypotheses must demonstrate PENG superiority while the other cannot demonstrate inferiority.

NCT ID: NCT05118399 Completed - Acute Pain Clinical Trials

Analgesic Effect of Liposomal Bupivacaine

Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. A number of clinical trials have studied the effect liposomal bupivacaine given as local infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block - which is used for regional anaesthesia for distal radial fracture surgery - have not been studied before. This project is a randomized controlled trial to determine whether adding liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve and prolong postoperative analgesia in patients undergoing distal radial fracture surgery. Longer term secondary outcomes would be accessed including upper limb functional scores, chronic pain, and health related quality of life.

NCT ID: NCT05114265 Completed - Acute Pain Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults

Start date: February 15, 2022
Phase: Phase 1
Study type: Interventional

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single doses of a new drug called KUR-101. Up to 58 healthy men or women aged between 18-55 will be enrolled in this study in two parts. Part 1 will involve a single ascending (increasing) dose (SAD) where 40 participants (5 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. Part 2: will involve a crossover design where 18 participants will be randomised to receive a single oral dose of each of three interventions (study drug, placebo or a marketed form of oxycodone). Each dose is separated by 7 days and the participants are randomised so they do not know the order of the interventions. For Part 1 the total participation will last 9 days, of which 4 days (3 nights) will be spent in the clinic. One group of subjects in Part 1 will return to the clinic to receive a second dose of drug given with a high fat breakfast. In this group, the total participation will last 16 days, of which 8 days (7 nights) will be spent in the clinic. For Part 2 the total participation will last 23 days, of which 9 days (8 nights) will be spent in the clinic.

NCT ID: NCT05103800 Completed - Pain, Acute Clinical Trials

Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns

IEWNLPCDIIN
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Comfort, distress and the absence of pain can be described as free from anxiety, somewhat enjoyable and ease (peaceful) situation. The child health and disease nurse should come up with physiological problems of the baby, increase the comfort degree to reduce the stress level of the baby and ensure improvement in the baby's location. This research was experimentally designed to investigate the effect of the baby's own intrauterine heart sound on pain and comfort during the invasive procedures applied to the healthy born babies in the delivery units of the Batman Gynecology and Pediatrics Hospital. The research will be performed by selecting samples in a simple random sampling method from the babies who born healthy and timely in the normal vaginal way. The number of samples will be determined by power analysis method after pilot study. The previously white noise will have listened to the babies in experimental group and will be recorded by camera during invasive interventions and the pain and comfort scale will be applied. The scales will be applied to the control group let them without listening White noise but also will be recorded with camera and thus the data will be collected. A nurse working in the unit will perform invasive interventions, later two specialists will watch video records and so the pain and comfort scales will be filled. No study on this subject was found in the international literature review. Based on the need to fill this gap in the literature, it seems that the study will contribute to the field of child health and diseases nursing.