Acute Pain

Researchers are evaluating the use of transversus abdominis plane (TAP) block with different adjuvants to improve pain relief after laparotomy surgery. This study compares the addition of dexamethasone or dexmedetomidine to bupivacaine in patients aged 25 to 65 years with ASA Class I or II status. The goal is to assess which combination provides longer-lasting postoperative analgesia and reduces the need for additional pain medication. Participants will be randomly assigned to one of two groups. Group A receives a TAP block with 18ml of 0.25% bupivacaine plus 2ml of dexamethasone (8mg). Group B receives the same bupivacaine dose plus 2ml of dexmedetomidine (1µg/kg diluted in saline). The TAP block is administered bilaterally under ultrasound guidance immediately after surgery, using a needle guided between the internal oblique and transversus abdominis muscles. Patients are monitored for complications like local anesthetic toxicity or hematoma. During the 24-hour postoperative period, patients' pain levels will be measured using a Visual Analogue Scale (VAS) at several time points. If pain is insufficiently controlled (VAS ≥4), rescue analgesia with IV ketorolac will be provided and the time to first rescue dose recorded. Additional assessments include monitoring nausea, vomiting, heart rate, and blood pressure. The primary outcome is the duration until the first request for rescue analgesia, with secondary outcomes focused on pain scores over 24 hours.

This research aims to compare the effectiveness of topical lignocaine ointment versus 0.2% glyceryl trinitrate (GTN) ointment for reducing postoperative pain and promoting wound healing in patients undergoing hemorrhoidectomy. Hemorrhoids are swollen veins in the anal area, and pain after surgery can delay recovery and affect comfort. The study focuses on determining which ointment provides better pain relief and wound healing outcomes following hemorrhoid removal surgery. Patients undergoing hemorrhoidectomy will be randomly assigned to one of two groups. One group will receive lignocaine ointment applied locally to the anal wound three times daily after surgery, while the other group will receive 0.2% GTN ointment on the same schedule. Both groups will receive standard postoperative care including sitz baths, stool softeners, and paracetamol for pain relief. The study will follow participants for 3 to 6 months overall, with treatment and monitoring focused on the first month after surgery. Participants will have their pain levels assessed using a visual analog scale (VAS) at various times after surgery, including 6, 12, 24, 48, and 72 hours, as well as at 7, 14, 21, and 28 days. Wound healing time will be tracked up to one month, and patient satisfaction will be measured at 6 weeks using a 5-point scale. Additional monitoring includes recording the time to first analgesic request, analgesia amounts, and any side effects such as wound secretion, itching, bleeding, or headaches. Data will be analyzed to compare outcomes between the two ointments.

This research aims to understand how thumb-tack needle therapy affects sleep and recovery after surgery in patients who have undergone general anesthesia for breast cancer surgery. The study focuses on improving postoperative sleep quality, preventing sleep disorders, and promoting recovery following surgery. Participants are women aged 18 to 55 years with no history of chronic insomnia or recent use of sedative-hypnotic drugs. Participants in this observational study will undergo thumb-tack needle therapy as part of their postoperative care. The therapy's impact will be monitored without assigning different treatment groups. The study will follow patients before and after anesthesia exposure to observe changes in sleep quality and recovery. During the study, researchers will assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI) one or two days before anesthesia and on days 1, 3, and 7 after anesthesia. Recovery will also be evaluated with the QoR-40 questionnaire on the third day after surgery. The study monitors patient progress to explore the clinical significance of thumb-tack needle therapy in improving postoperative outcomes.

Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are studying whether a continuous intravenous lidocaine infusion after major reconstructive spinal surgery can reduce the risk and severity of postoperative delirium and lessen opioid-related side effects in elderly patients. Postoperative delirium is common after non-cardiac surgery and linked to poor outcomes, with poor pain control being a modifiable risk factor. This study is a randomized, double-blinded, placebo-controlled trial involving 60 patients undergoing major elective spine surgery involving more than three levels of instrumentation and fusion. Participants will be randomly assigned to receive either a lidocaine infusion at 1.33 mg/kg/hr based on adjusted body weight or a placebo (D5 water) intravenously for 48 hours following surgery. Anesthetic management during surgery is standardized with total intravenous anesthesia including propofol, lidocaine, magnesium, fentanyl, and sevoflurane. The lidocaine infusion or placebo begins postoperatively before discharge from the post-anesthetic care unit or upon intensive care unit arrival. During the study, participants will be monitored for the incidence and severity of postoperative delirium from 24 hours after starting the infusion to 3 days post-surgery. Researchers will also assess opioid use, pain scores, opioid-related side effects, analgesic satisfaction, functional recovery using surveys and physical therapy participation, time to discharge, and cognitive function up to 3 months. Safety and tolerability of lidocaine will be closely observed, with continuous monitoring during and after surgery. The total follow-up includes assessments up to hospital discharge and longer-term functional outcomes at 3 months.

Researchers are investigating treatments for temporomandibular disorders (TMD), which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups: one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5's effects, including psychological responses and potential fluid biomarkers. The study consists of three parts: Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels; Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels; and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo (vehicle) are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5's effects and safety.

Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.

This research aims to learn more about vitamin C deficiency in patients with either acute or chronic diseases. It focuses on understanding how symptoms change over time and how well patients tolerate treatment. The study involves patients diagnosed with vitamin C deficiency either by lab tests or based on symptoms such as fatigue, infections, bleeding gums, joint pain, and poor wound healing. The study observes patients treated with Vitamin C Injektopas® 7.5 g, given for an expected average of about 3 weeks for acute diseases or 12 weeks for chronic diseases. Two groups are included: those with acute underlying diseases and those with chronic underlying diseases, both receiving this vitamin C therapy during the study period. Participants will be followed to assess changes in general and disease-specific symptoms, as well as treatment tolerability and overall effectiveness from the patient's perspective. Researchers will also record the number of vitamin C infusions and measure quality of life for chronic disease patients. The study duration ranges up to approximately 12 weeks, with evaluations at the last visit to understand symptom improvement and treatment impact.

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.