[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intraoperative-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intraoperative-pain":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,74,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100619157","sensory-stimuli-during-cesarean-delivery-100619157",false,"NCT07340970","Sensory Stimuli During Cesarean Delivery","Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER): A Multicenter Prospective Cohort Study","PIONEER-MC","Inclusion Criteria:\n\n* Pregnant and 19 years of age or older\n* Single (one) baby at 37 weeks of pregnancy or later\n* Overall health classified as American Society of Anesthesiologists (ASA) Physical Status II or III\n* Scheduled for a planned (elective) cesarean delivery using spinal anesthesia (single-shot spinal or combined spinal-epidural)\n* Able to describe sensations in their own words in one of the study's available languages\n* Willing and able to give written informed consent before any study procedures\n* Willing and able to complete online follow-up questionnaires at 6 weeks, 3 months, and 6 months after delivery\n\nExclusion Criteria:\n\n* History of a chronic pain condition (for example, fibromyalgia, chronic pelvic pain, complex regional pain syndrome, or chronic low back pain requiring ongoing treatment)\n* Regular use of opioids, gabapentinoids (gabapentin or pregabalin), or other centrally acting pain medications during the current pregnancy (occasional acetaminophen use is allowed)\n* History of a neurological condition that can affect normal sensation (for example, peripheral neuropathy, multiple sclerosis, or spinal cord injury)\n* Pregnancy with more than one baby (twins or more)\n* Cesarean delivery planned with an anesthesia method other than single-shot spinal or combined spinal-epidural (for example, topping up an existing labor epidural, or general anesthesia)\n* Known major fetal abnormality or an expected newborn complication likely to require immediate admission to the neonatal intensive care unit (NICU)\n* Known allergy or other reason the local anesthetic medications used for spinal anesthesia cannot be given\n* Active substance use disorder","FEMALE","19 Years",{"count":20,"type":21},1005,"ESTIMATED","OBSERVATIONAL","During a cesarean delivery (C-section), most patients are awake and receive spinal or epidural anesthesia to block pain from the lower body. Even when this anesthesia works well, many patients still feel sensations during surgery, such as pulling, pressure, tugging, or, in some cases, pain. In the past, studies have mostly focused on whether patients felt \"pain,\" and have often relied on patients remembering their experience afterward or on the surgical team's judgment of how the patient was doing. These approaches can miss sensations that bother the patient but are not clearly described as pain, and they may not reflect what the patient actually wanted done at the time.\n\nThis study takes a different approach. Instead of asking only about pain, the researchers will ask patients, in real time during their C-section, what they are feeling in their own words, and whether they would like the medical team to do something about it (such as giving medication). The main idea is that the patient's own request for help, rather than someone else's opinion about how severe a sensation is, should be what counts as a moment that matters.\n\nThe main purpose of the study is to find out how often patients undergoing a planned C-section ask for medication in response to a sensation they feel during surgery. The researchers will ask each patient at six specific points during the operation whether they feel any sensation, how they would describe it, and whether they would like the team to act. Patients will also rate how strong each sensation is and point to where on the body they feel it. All decisions about care will remain entirely with the patient's own medical team; the research team only records what the patient reports and what care is given.\n\nThe study is also designed to answer several related questions:\n\n* What words and descriptions do patients naturally use for the sensations they feel during a C-section?\n* How often are sensations that patients do not call \"painful\" still bothersome enough that the patient asks for medication?\n* How do patients' feelings and mental health change over the first six months after delivery, including symptoms of post-traumatic stress, depression, and birth-related distress?\n* Does a patient's anxiety before surgery affect what they feel during surgery or how likely they are to ask for help?\n\nThe main question the study is trying to answer is: How often do patients undergoing a planned cesarean delivery ask for medication because of something they feel during the operation?\n\nThe researchers' hypothesis is that this number will be higher than what earlier pain-focused studies have reported. Specifically, they expect that more than 11.5 percent of patients will ask for medication during surgery, which is greater than the rate of pain requiring extra medication found in a similar previous study. If correct, this would suggest that the true number of patients who experience moments during a C-section when they want help has been underestimated by traditional methods that focus only on pain.\n\nThis is an observational study. It does not test a new drug or change how anesthesia or surgery is performed. Instead, it carefully observes and records patients' experiences in order to better understand what patients feel during a cesarean delivery, how often they want the team to act, and how these experiences relate to their recovery and emotional well-being afterward. The goal is to use this information to improve the comfort, care, and long-term well-being of patients having a C-section.",[25],"Intraoperative Pain",[27,28,29,30,31],"cesarean delivery","neuraxial anesthesia","intraoperative pain","intraoperative sensation","peritraumatic distress","RECRUITING","2026-07-29",{"date":35,"type":36},"2026-08-03","ACTUAL",{"date":38,"type":21},"2026-07-20",{"date":40,"type":21},"2027-09-30",{"name":42,"class":43},"University of British Columbia","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100621106","management-of-indwelling-labor-epidural-catheters-for-cesarean-delivery-100621106","NCT07366307","Management of Indwelling Labor Epidural Catheters for Cesarean Delivery","Management of Indwelling Labor Epidural Catheters and Pain During Cesarean Delivery: a Prospective Single-center Patient-reported Outcome Study","Inclusion Criteria:\n\n* ages 18-50 years\n* had cesarean delivery at Baylor Scott \\& White Medical Center from January 1, 2026 through December 31, 2026\n* Fluent in the English language (our catastrophizing survey is validated in English language only)\n* Can provide their own consent\n* Identifies as Black or African American only, Hispanic, or White or Caucasian only\n* had administration of local anesthetic through indwelling labor epidural or removal of indwelling labor epidural followed by single injection spinal or combined spinal epidural\n\nExclusion Criteria:\n\n* less than 18 years old, older than 50 years old\n* had cesarean delivery at Baylor Scott \\& White Medical Center before January 1, 2026 or after December 31, 2026\n* Employee of Baylor Scott \\& White Health labor and delivery unit\n* Student of a school that performs clinical rotations at Baylor Scott \\& White Medical Center-Temple\n* Incarcerated at the time of study enrollment\n* Underwent scheduled cesarean hysterectomy\n* Underwent cesarean delivery with general anesthesia as either the primary anesthetic technique or had conversion to general anesthesia because of failure of neuraxial anesthesia\n* Admitted to the intensive care unit immediately following cesarean delivery\n* Did not have intrathecal morphine or intrathecal fentanyl if receiving spinal anesthesia\n* Had anesthesia for an attempted external cephalic version within 24 hours of cesarean delivery",true,"18 Years","50 Years",{"count":56,"type":21},200,"This is a prospective observational study that will survey patients who had an indwelling labor epidural catheter and subsequently underwent cesarean delivery. We hypothesize that patients who had removal of indwelling labor epidural catheters and had a new neuraxial anesthetic technique attempted will have a lower incidence of self-reported pain during cesarean delivery compared to patients who had top up of their indwelling labor epidural catheters.",[25],[60,61,62,63],"cesarean section","pain","labor epidural catheter","top up","NOT_YET_RECRUITING","2026-01-16",{"date":67,"type":36},"2026-01-26",{"date":69,"type":21},"2026-01-01",{"date":71,"type":21},"2026-12-31",{"name":73,"class":43},"Baylor Research Institute",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100593138","pecs-ii-vs-esp-in-nociception-level-index-guided-breast-surgery-100593138","NCT07002541","PECS-II vs ESP in Nociception Level Index Guided Breast Surgery","NOL-Guided Intraoperative Remifentanil Consumption With PECS-II and Erector Spinae Plane Blocks in Breast Surgery: A Randomized Controlled Trial","NOL","Eligibility Criteria This study involves adult female patients undergoing elective breast surgery for benign or malignant conditions. The goal is to evaluate the effectiveness of regional anesthesia techniques (PECS-II and ESP blocks) in reducing intraoperative opioid consumption, guided by Nociception Level Index (NOL) monitoring.\n\nInclusion Criteria:\n\nFemale patients aged 18 to 80 years ASA Physical Status Classification I-III\n\nScheduled for elective unilateral or bilateral breast surgery, including one or more of the following:\n\nLumpectomy with axillary lymph node biopsy or dissection Breast reconstruction Breast reduction Mastopexy Implant expander removal or placement\n\nExclusion Criteria:\n\nMorbid obesity (BMI \\> 40 kg\u002Fm²) Presence of non-sinus cardiac rhythm Chronic opioid use (defined as daily use for \\>2 weeks in the last month or total use \\>4 weeks) History of opioid abuse or dependence Comorbidities causing moderate to severe functional limitation Inability to communicate with study personnel or follow instructions Pregnancy or breastfeeding Known allergy or hypersensitivity to bupivacaine or any study-related medication\n\n\\-","80 Years",{"count":84,"type":21},90,"INTERVENTIONAL",[87],"NA","Background:\n\nBreast surgery is often associated with significant perioperative pain. While systemic opioids are commonly used, their side effects (nausea, vomiting, respiratory depression, delayed recovery) have encouraged the adoption of regional anesthesia techniques for better analgesia and reduced opioid requirements. PECS-II and Erector Spinae Plane (ESP) blocks are two effective regional techniques frequently utilized in breast surgery. However, comparative data on their impact on intraoperative opioid consumption under nociception-guided anesthesia remains limited.\n\nThe Nociception Level Index (NOL) is an objective monitoring tool that integrates multiple physiological signals (e.g., heart rate variability, skin conductance, pulse amplitude) to assess nociceptive responses in real-time. When used intraoperatively, it enables more precise opioid titration, potentially optimizing analgesia while minimizing opioid exposure.\n\nObjective:\n\nTo compare the efficacy of PECS-II and ESP blocks in reducing intraoperative remifentanil consumption during breast surgery under general anesthesia guided by NOL monitoring.\n\nMethods:\n\nThis prospective, randomized controlled trial was conducted at Koç University Hospital following ethical approval. Ninety female patients aged 18-80 years, classified as ASA I-III and scheduled for elective mastectomy or other breast surgeries, were randomly assigned into three groups (n=30 each):\n\nGroup 1 (PECS-II Block) Group 2 (ESP Block) Group 3 (Control - no block) Regional blocks were performed before surgery with ultrasound guidance. PECS-II block was administered at the 3rd to 5th rib levels in the mid-axillary line using 30 mL of 0.3% bupivacaine. ESP block was applied at T2-T5 levels with a total of 20 mL 0.5% bupivacaine.\n\nAll patients received standardized general anesthesia, including propofol, fentanyl, rocuronium, and desflurane maintenance. Remifentanil infusion (0.05-0.1 μg\u002Fkg\u002Fmin) was titrated based on NOL values every 5 minutes: increased by 0.03 μg\u002Fkg\u002Fmin if NOL \\>25, and decreased by 0.03 μg\u002Fkg\u002Fmin if NOL \\\u003C10.\n\nData collected included:\n\nTotal intraoperative remifentanil consumption (primary outcome) NOL scores every 5 minutes Postoperative pain scores (NRS) at 1st, 6th, 12th, and 24th hours (at rest and with arm abduction) Total opioid consumption (morphine, tramadol) in the first 24 hours Opioid-related side effects (nausea, vomiting, pruritus) Length of hospital stay Blinding was applied to data collectors (pain nurses and anesthesia technicians), but due to the nature of the procedures, surgeons and anesthesiologists were not blinded.\n\nStatistical Analysis:\n\nData were analyzed using SPSS v26. Continuous variables were tested for normality (Shapiro-Wilk), and analyzed with t-tests or Mann-Whitney U as appropriate. Categorical variables were compared using Chi-square tests. Significance was set at p\\\u003C0.05.\n\nExpected Outcomes and Contribution:\n\nIt is hypothesized that both PECS-II and ESP blocks will significantly reduce intraoperative remifentanil consumption compared to the control group. Furthermore, these blocks may improve postoperative pain control, reduce opioid-related side effects, and shorten recovery time.\n\nThis study aims to clarify the relative efficacy of two widely used regional blocks in the context of objective, nociception-guided anesthesia. The findings are expected to support evidence-based use of regional techniques in breast surgery and contribute to the growing body of literature emphasizing opioid-sparing strategies in perioperative care.",[25,90],"Postoperative Pain","2025-05-24",{"date":93,"type":36},"2025-06-03",{"date":95,"type":36},"2024-12-01",{"date":97,"type":21},"2025-06-30",{"name":99,"class":43},"Koç University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":85,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100559915","phase-4-analgesic-efficacy-of-intrathecal-fentanyl-morphine-combination-versus-morphine-alone-for-intraoperative-pain-during-elective-cesarean-delivery-100559915","NCT06570343","Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery","Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Parturients of gestational age \\> 37 weeks, scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia\n* Any sign of onset of labor\n* Emergency cesarean section\n* Body weight \\\u003C 40 kg or \\> 120 kg\n* Height \\\u003C 140 cm or \\> 190 cm\n* Severe underlying cardiovascular disease\n* Known fetal anomaly\n* Preeclampsia\n* History of hypersensitivity to fentanyl or morphine\n* Chronic opioid use","99 Years",{"count":109,"type":21},186,[111],"PHASE4","Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.",[25],"2024-09-29",{"date":116,"type":36},"2024-10-01",{"date":118,"type":21},"2024-09-20",{"date":120,"type":21},"2025-12-25",{"name":122,"class":43},"Seoul National University Hospital"]