[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658547":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":64,"overallOfficials":94,"centralContacts":98,"locations":103,"responsibleParty":128,"collaborators":131,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":30,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":166,"whyStopped":30,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Intensity of visceral pain at 16 hours postoperatively","Visceral pain intensity will be assessed using the Numerical Rating Scale (NRS, 0-10) at 2, 4, 8, 12, and 16 hours after surgery. The primary endpoint is the NRS score at 16 hours. Visceral pain is defined as dull, cramping lower abdominal pain.","2, 4, 8, 12, and 16 hours postoperatively",[14,17,21,24,27],{"measure":15,"description":16,"timeFrame":12},"Intensity of somatic pain at 16 hours postoperatively","Somatic pain intensity (incisional pain) will be assessed using the Numerical Rating Scale (NRS, 0-10) at the same time points as visceral pain.",{"measure":18,"description":19,"timeFrame":20},"Time to first independent mobilization","Time (in hours) from the end of surgery to the patient's first attempt to sit up or stand without assistance.","Within 24 hours postoperatively",{"measure":22,"description":23,"timeFrame":20},"Time to first mother-infant skin-to-skin contact","Time (in hours) from the end of surgery to the first sustained skin-to-skin contact between the mother and the newborn.",{"measure":25,"description":26,"timeFrame":20},"Consumption of rescue analgesia","Number of patients requiring rescue analgesia (trimeperidine 20 mg IM) due to NRS pain score \\> 4.",{"measure":28,"description":29,"timeFrame":20},"Incidence of adverse events","Frequency of hypotension, nausea, vomiting, pruritus, and signs of local anesthetic systemic toxicity (LAST).",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Three parallel groups with a 1:1:1 allocation ratio. Group 1 receives bilateral ESP block, Group 2 receives bilateral TAP block, and Group 3 receives standard analgesia without blocks.","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","This is a single-blind study. Patients and outcome assessors are blinded to group allocation. The anesthesiologist performing the block is unblinded due to the nature of the intervention.",[40,41],"PARTICIPANT","OUTCOMES_ASSESSOR","Background:\n\nPostoperative pain after cesarean delivery has a dual nature: a somatic component resulting from the abdominal wall incision and a visceral component arising from uterine contraction and tissue trauma (innervated by Th10-L1 segments). According to PROSPECT (2021) guidelines, multimodal analgesia is the standard of care. Interfascial plane blocks, such as the Transversus Abdominis Plane (TAP) block and the Erector Spinae Plane (ESP) block, have shown efficacy in controlling somatic pain. However, data comparing their differential efficacy on visceral versus somatic pain components are limited. The ESP block, performed at the L1 level, theoretically offers superior visceral analgesia due to the spread of local anesthetic to the dorsal rami of spinal nerves and potential craniocaudal spread into the paravertebral\u002Fepidural space.\n\nStudy Design:\n\nThis is a prospective, single-center, randomized, single-blind controlled trial conducted at the Maternity Hospital in Taganrog, Rostov Oblast, Russia. A total of 162 patients undergoing elective cesarean delivery under spinal anesthesia will be enrolled. Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups:\n\n1. ESP Block Group: Patients will receive a bilateral ultrasound-guided ESP block at the L1 level in the post-anesthesia care unit. 20 mL of 0.375% ropivacaine will be injected on each side (total 40 mL).\n2. TAP Block Group: Patients will receive a bilateral ultrasound-guided TAP block in the post-anesthesia care unit. 20 mL of 0.375% ropivacaine will be injected on each side (total 40 mL).\n3. Control Group: Patients will receive standard postoperative analgesia without interfascial blocks. This includes ketoprofen 100 mg IM at 4 hours, and oral paracetamol + ketoprofen at 12 hours. Rescue analgesia (trimeperidine 20 mg IM) will be provided if the pain score exceeds 4 on the Numerical Rating Scale (NRS).\n\nAll patients will undergo spinal anesthesia with hyperbaric bupivacaine 0.5% (2.2 mL) at the L2-L3 interspace. Preoperatively, pain threshold will be assessed using Nevidimova's method.\n\nOutcome Measures:\n\nThe primary outcome is the intensity of visceral pain measured by the Numerical Rating Scale (NRS, 0-10) at 2, 4, 8, 12, and 16 hours postoperatively. Visceral pain is defined as dull, cramping lower abdominal pain.\n\nSecondary outcomes include:\n\n* Intensity of somatic pain (NRS 0-10) at the same time points.\n* Time to independent mobilization (hours).\n* Time to first mother-infant skin-to-skin contact (hours).\n* Consumption of rescue analgesia (number of trimeperidine injections).\n* Incidence of adverse events (hypotension, nausea, vomiting, pruritus, signs of local anesthetic systemic toxicity).\n\nStatistical Analysis:\n\nBased on a power analysis (80% power, α=0.05), a minimum of 54 patients per group (162 total) is required to detect a clinically significant difference of 1.5 points in visceral pain scores. Data will be analyzed using the Kruskal-Wallis test for between-group comparisons and the Friedman test for within-group dynamics. A p-value \\\u003C 0.05 will be considered statistically significant.\n\nEthical Considerations:\n\nThe study is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants will provide written informed consent. Personal data will be coded and stored securely. The study has been approved by the Local Ethics Committee of I.M. Sechenov First Moscow State Medical University.",[44,53,58],{"label":45,"type":46,"description":47,"interventionNames":48},"Experimental: ESP Block Group","EXPERIMENTAL","Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) PLUS bilateral ultrasound-guided ESP block at L1 level (20 mL of 0.375% ropivacaine per side). No trimeperidine is administered in this group.",[49,50,51,52],"Drug: Ropivacaine","Procedure: Ultrasound-guided Nerve Block","Drug: Ketoprofen and Paracetamol","Procedure: Ultrasound-guided ESP Block",{"label":54,"type":46,"description":55,"interventionNames":56},"Experimental: TAP Block Group","Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) PLUS bilateral ultrasound-guided TAP block (20 mL of 0.375% ropivacaine per side). No trimeperidine is administered in this group.",[49,50,51,57],"Procedure: Ultrasound-guided TAP Block",{"label":59,"type":60,"description":61,"interventionNames":62},"Active Comparator: Standard Analgesia Group","ACTIVE_COMPARATOR","Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) WITHOUT interfascial blocks. Rescue analgesia with trimeperidine 20 mg IM is available if NRS \\> 4.",[51,63],"Drug: Trimeperidine (Rescue)",[65,70,75,79,83,87,91],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":30},"DRUG","Ropivacaine","0.375% solution for ultrasound-guided nerve blocks.",[45,54],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":30},"PROCEDURE","Ultrasound-guided Nerve Block","Bilateral TAP or ESP block performed in the post-anesthesia care unit.",[45,54],{"type":66,"name":76,"description":77,"armGroupLabels":78,"otherNames":30},"Ketoprofen and Paracetamol","Baseline multimodal analgesia administered to ALL groups: Ketoprofen 100 mg IM at 4 hours postoperatively, followed by oral paracetamol + ketoprofen at 12 hours.",[59,45,54],{"type":66,"name":80,"description":81,"armGroupLabels":82,"otherNames":30},"Trimeperidine (Rescue)","Rescue analgesia (Trimeperidine 20 mg IM) administered ONLY in the Control Group if NRS pain score \\> 4.",[59],{"type":71,"name":84,"description":85,"armGroupLabels":86,"otherNames":30},"Ultrasound-guided ESP Block","Bilateral ESP block at L1 level with 20 mL of 0.375% ropivacaine per side.",[45],{"type":71,"name":88,"description":89,"armGroupLabels":90,"otherNames":30},"Ultrasound-guided TAP Block","Bilateral TAP block with 20 mL of 0.375% ropivacaine per side.",[54],{"type":66,"name":67,"description":92,"armGroupLabels":93,"otherNames":30},"0.375% solution for nerve blocks.",[45,54],[95],{"name":96,"affiliation":5,"role":97},"Aleksandr A. Bezverkhiy, PhD","PRINCIPAL_INVESTIGATOR",[99],{"name":96,"role":100,"phone":101,"phoneExt":30,"email":102},"CONTACT","+79034300922","aab@arekusand.ru",[104],{"facility":5,"status":30,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Taganrog","Rostov Oblast","347900","Russia","RU",{"type":111,"coordinates":112},"Point",[113,114],38.9053,47.23627,{"lat":114,"lon":113},[117,118,119,122,124,126],{"name":96,"role":100,"phone":101,"phoneExt":30,"email":102},{"name":96,"role":97,"phone":30,"phoneExt":30,"email":30},{"name":120,"role":121,"phone":30,"phoneExt":30,"email":30},"Larisa V. Smekalkina, Professor","SUB_INVESTIGATOR",{"name":123,"role":121,"phone":30,"phoneExt":30,"email":30},"Nikolay N. Chernov, Professor",{"name":125,"role":121,"phone":30,"phoneExt":30,"email":30},"Daria V. Glotova, MD",{"name":127,"role":121,"phone":30,"phoneExt":30,"email":30},"Sergey V. Zdiruk, PhD",{"type":97,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Alexander Bezverkhiy","Head of Department of Anaesthesiology and Intensive Care; Associate Professor, Southern Federal University (Advanced Engineering School); PhD in Engineering",[132],{"name":133,"class":134},"I.M. Sechenov First Moscow State Medical University","OTHER","100658547","tap-vs-esp-blocks-for-post-cesarean-analgesia-a-randomized-controlled-trial-100658547",false,"NCT07853482","TAP vs. ESP Blocks for Post-Cesarean Analgesia","Comparative Efficacy of Transversus Abdominis Plane (TAP) and Erector Spinae Plane (ESP) Blocks for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Single-Center, Randomized Controlled Trial","RCT-TAP-ESP-CS","Inclusion Criteria:\n\n1. Women aged 18 to 40 years.\n2. ASA physical status I-II.\n3. Scheduled for elective cesarean delivery under spinal anesthesia at term (37-41 weeks of gestation).\n4. Single fetus pregnancy.\n5. Provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Emergency cesarean delivery.\n2. Contraindications to regional anesthesia (e.g., coagulation disorders, infection at the injection site, patient refusal).\n3. Known allergy to local anesthetics (ropivacaine, bupivacaine) or NSAIDs (ketoprofen).\n4. Chronic pain syndrome or regular use of opioid analgesics prior to surgery.\n5. BMI \\> 35 kg\u002Fm².\n6. Multiple pregnancy (twins, triplets, etc.).\n7. Pre-eclampsia or eclampsia.\n8. Inability to communicate or understand the pain assessment scales (NRS).\n9. Previous abdominal surgery with extensive adhesions that may alter anatomy for nerve blocks.","FEMALE","18 Years","40 Years",{"count":147,"type":148},162,"ESTIMATED","INTERVENTIONAL",[151],"NA","This study compares the effectiveness of two ultrasound-guided nerve blocks (TAP block and ESP block) versus standard pain management for relieving pain after a planned cesarean section.\n\nCesarean delivery often causes moderate to severe pain, which can be divided into somatic pain (from the abdominal incision) and visceral pain (from uterine contractions and internal tissues). While transversus abdominis plane (TAP) blocks are commonly used, erector spinae plane (ESP) blocks are a newer technique that may provide better relief for visceral pain.\n\nIn this randomized controlled trial, 162 women undergoing elective cesarean delivery under spinal anesthesia will be assigned to one of three groups:\n\n1. Bilateral ESP block at the L1 level;\n2. Bilateral TAP block;\n3. Standard analgesia without nerve blocks.\n\nThe primary goal is to determine which method provides better control of visceral pain in the first 16 hours after surgery. Secondary goals include assessing somatic pain, time to first mobilization, time to first skin-to-skin contact with the baby, and the need for additional rescue pain medication. The study aims to support early recovery and improve mother-infant bonding by optimizing postoperative pain control.",[154],"Postoperative Pain After Cesarean Section",[156,157,158,159,160,161,162,163,164,165],"Cesarean section","postoperative pain","TAP block","ESP block","erector spinae plane block","transversus abdominis plane block","regional anesthesia","visceral pain","somatic pain","ropivacaine","NOT_YET_RECRUITING","2026-10-01",{"date":169,"type":170},"2026-10-06","ACTUAL",{"date":172,"type":148},"2026-10-15",{"date":174,"type":148},"2027-06-10",{"name":5,"class":6},1]