[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659730":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":37,"studyPopulation":25,"armGroups":38,"interventions":50,"overallOfficials":63,"centralContacts":70,"locations":76,"responsibleParty":93,"collaborators":25,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":25,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Udayana University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Total fentanyl consumption via patient-controlled analgesia (PCA) in the first 24 hours after surgery","Cumulative fentanyl dose delivered through the PCA pump over the first 24 hours after surgery, read from the cumulative PCA pump log at 24 hours and expressed in mcg per kg body weight. PCA settings: fentanyl 10 mcg\u002FmL, demand only, demand dose 20 mcg, lockout interval 10 minutes, maximum 200 mcg per 4 hours, no background infusion, identical in both groups.","24 hours after surgery",[14,17,21],{"measure":15,"description":15,"timeFrame":16},"Postoperative pain intensity (Numerical Rating Scale, 0-10)","Self-reported pain intensity on the Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable), obtained by guided interview by a blinded Acute Pain Service assessor.",{"measure":18,"description":19,"timeFrame":20},"Time to first rescue analgesia","Time in minutes from arrival at the Post-Anesthesia Care Unit (PACU) until the participant first requires rescue analgesia for pain with NRS of 4 or higher, taken from nursing records and the PCA pump log by a blinded assessor. Rescue analgesia is a 20 mcg fentanyl bolus delivered through the PCA pump. Participants who need no rescue analgesia within 24 hours are recorded as 1440 minutes.","Up to 24 hours after surgery",{"measure":22,"description":23,"timeFrame":24},"Quality of Recovery-15 (QoR-15) score","Total score of the 15-item patient-reported Quality of Recovery questionnaire (Indonesian version), each item scored 0-10, total 0-150 (higher score = better recovery), completed by the participant and assessed by a blinded assessor.","24 +\u002F- 2 hours after surgery",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Two-arm, parallel-group randomized trial with block randomization. Each participant receives either an ultrasound-guided MTP block or an ultrasound-guided ESP block (ropivacaine 0.375% 20 mL, single injection, T4-T5) after induction of general anesthesia.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"DOUBLE","Participants receive the block after induction of general anesthesia and are unaware of the block type. All outcomes are assessed by the Acute Pain Service team, who are blinded to allocation. The block operator (consultant anesthesiologist) opens the sealed opaque randomization envelope and performs the block according to allocation, but does not assess outcomes. The block operator is not masked.",[35,36],"PARTICIPANT","OUTCOMES_ASSESSOR","Background and rationale Postoperative pain of moderate to severe intensity is still common in the first 24 hours after video-assisted thoracoscopic surgery (VATS) despite its minimally invasive nature. Inadequately treated pain can lead to splinting, atelectasis and chronic post-surgical pain. At RS Ngoerah, postoperative analgesia after VATS is not yet standardized and relies on intravenous systemic opioids or thoracic epidural anesthesia. Ultrasound-guided fascial plane blocks are recommended as components of enhanced recovery protocols.\n\nThe erector spinae plane (ESP) block places local anesthetic in the fascial plane between the erector spinae muscle and the transverse process. Analgesia depends mainly on blockade of the dorsal rami, and spread to the thoracic paravertebral space is variable. The midpoint transverse process to pleura (MTP) block places the needle tip midway between the posterior edge of the transverse process and the pleura. It is closer to the thoracic paravertebral space but still posterior to the superior costotransverse ligament, and is expected to give more reliable spread to the paravertebral space, with a theoretically higher risk of pneumothorax than the ESP block. To the investigators' knowledge, no randomized trial has directly compared the two blocks exclusively in VATS, and the Quality of Recovery-15 (QoR-15) has not been compared between them in thoracic surgery.\n\nStudy design Randomized, double-blind, parallel-group controlled trial at a single center (Central Surgical Installation, RS Ngoerah, Denpasar, Indonesia) in adult patients undergoing elective VATS. Outcomes are measured only after the intervention, without a baseline measurement, because baseline conditions of the two groups are assumed to be equal through randomization. Participants receive the block after induction of general anesthesia and are therefore unaware of the block type. Outcomes are assessed by the Acute Pain Service (APS) team, who are blinded to group allocation. The blocks are performed by a consultant anesthesiologist (regional analgesia consultant) of the Department of Anesthesiology and Intensive Therapy, RS Ngoerah, who follows the randomization envelope and does not assess outcomes.\n\nParticipants and sampling Consecutive sampling of eligible adult patients (age 18-65 years, ASA I-III, BMI 18-30 kg\u002Fm2) scheduled for elective VATS. Planned total sample size is 48 participants (24 per group).\n\nRandomization and allocation concealment Block randomization, with the list generated using randomizer.org. The list is kept in sealed, opaque, sequentially numbered envelopes that are opened only by the block operator shortly before the patient enters the operating room, after eligibility is confirmed. The allocated block is recorded by the operator and is not communicated to the assessor or the patient.\n\nPerioperative protocol Preoperative: eligibility screening by the investigator, written informed consent, education on PCA use, and recording of baseline data (age, sex, BMI, ASA status, diagnosis, planned VATS procedure, INR, platelet count, preoperative opioid use) from the medical record and direct measurement.\n\nIntraoperative: standard ASA monitoring. Induction with propofol 1.5-2.0 mg\u002Fkg, fentanyl 2 mcg\u002Fkg and rocuronium 0.6 mg\u002Fkg intravenously, with double-lumen tube intubation as required by the VATS procedure. Maintenance with sevoflurane 0.8-1 MAC and fentanyl 0.5-1 mcg\u002Fkg every 30-45 minutes, titrated to hemodynamic response. The block is performed under general anesthesia in the lateral decubitus position, at least 15 minutes before surgical incision (see intervention descriptions). VATS is performed by the thoracic surgery team of RS Ngoerah using standard technique. Ibuprofen 400 mg IV and paracetamol 1 g IV are given 30 minutes before wound closure in all participants.\n\nPostoperative (0-24 hours): fentanyl PCA is started immediately after arrival at the PACU (10 mcg\u002FmL, demand only, demand dose 20 mcg, lockout interval 10 minutes, maximum 200 mcg per 4 hours, no background infusion), programmed identically in both groups. If NRS is 4 or higher at a scheduled assessment, rescue analgesia is a 20 mcg fentanyl bolus delivered through the PCA pump and pressed by the patient. The time of the first rescue is recorded to the minute from nursing records or the PCA log.\n\nOutcome assessment All assessments are made by the blinded APS team. Total PCA fentanyl is read from the cumulative PCA pump log at 24 hours and expressed in mcg\u002Fkg. NRS (0-10) at rest and on movement is obtained by guided interview at 0, 1, 2, 4, 6, 12 and 24 hours after the end of surgery. Time to first rescue analgesia is taken from nursing records and the PCA log. The Indonesian version of the QoR-15 is completed by the participant at 24 +\u002F- 2 hours after surgery.\n\nSample size Sample size per group was calculated with the formula for unpaired numeric comparison (alpha 5%, power 90%) for four outcomes: total PCA fentanyl at 24 hours (16 per group), NRS at 12 hours (16 per group), time to first rescue analgesia (21 per group) and QoR-15 at 24 hours (17 per group). The largest requirement (21 per group) was adopted and, with a 10% drop-out allowance, 24 per group (48 in total) is planned.\n\nStatistical analysis Analysis is per-protocol: only participants who complete the protocol are analyzed. Numeric variables are summarized as mean and standard deviation or median and interquartile range, according to the distribution; categorical variables as frequency and percentage. Normality is tested with the Shapiro-Wilk test and homogeneity of variance with Levene's test. NRS scores at the seven time points are analyzed as repeated measures (repeated-measures ANOVA with group and time factors and the group x time interaction when data are normally distributed; non-parametric Friedman test otherwise). Total PCA fentanyl, time to first rescue analgesia and QoR-15 are compared between groups with the independent t-test, or the Mann-Whitney U test when assumptions are not met. Potential covariates (type of VATS procedure, duration of surgery, duration of anesthesia, intraoperative fentanyl) are included in the comparative analysis if baseline comparability testing shows a significant difference between groups. A p value below 0.05 is considered statistically significant. Software: IBM SPSS Statistics version 25.0 or R version 4.0 or higher.\n\nWithdrawal and drop-out criteria Conversion from VATS to open thoracotomy; technical failure of the regional block confirmed by the operator, so the participant does not receive the intervention as specified; death within the 24-hour follow-up; postoperative mechanical ventilation; complications during care such as local anesthetic systemic toxicity (LAST) or allergic reaction\u002Fanaphylaxis; withdrawal from the study at any time during data collection.\n\nSafety monitoring Signs and symptoms of LAST (agitation, seizure, arrhythmia), pneumothorax, and opioid adverse events (respiratory depression, postoperative nausea and vomiting, pruritus) are recorded systematically on the case report form. Serious adverse events are reported to the research ethics committee.\n\nEthics The protocol was approved by the Research Ethics Committee, Faculty of Medicine, Universitas Udayana (protocol number 2026.02.1.0705, approval date 3 June 2026). Written informed consent is obtained from all participants.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"MTP block","EXPERIMENTAL","Ultrasound-guided MTP block with ropivacaine 0.375% 20 mL single injection at T4-T5, performed under general anesthesia in the lateral decubitus position at least 15 minutes before incision. All participants also receive the same general anesthesia, ibuprofen 400 mg IV and paracetamol 1 g IV 30 minutes before wound closure, and postoperative fentanyl PCA (10 mcg\u002FmL, demand dose 20 mcg, lockout 10 minutes, no background infusion).",[44],"Procedure: Midpoint Transverse Process to Pleura (MTP) block",{"label":46,"type":41,"description":47,"interventionNames":48},"ESP block","Ultrasound-guided ESP block with ropivacaine 0.375% 20 mL single injection at T4-T5, performed under general anesthesia in the lateral decubitus position at least 15 minutes before incision. All participants also receive the same general anesthesia, ibuprofen 400 mg IV and paracetamol 1 g IV 30 minutes before wound closure, and postoperative fentanyl PCA (10 mcg\u002FmL, demand dose 20 mcg, lockout 10 minutes, no background infusion).",[49],"Procedure: Erector spinae plane (ESP) block",[51,58],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"PROCEDURE","Midpoint Transverse Process to Pleura (MTP) block","Performed under general anesthesia in the lateral decubitus position, at least 15 minutes before surgical incision. A linear transducer (10-15 MHz) is placed parasagittally 3 cm lateral to the midline at T4-T5, and the transverse process and pleura are identified. The midpoint between the posterior edge of the transverse process and the pleura is determined. A 22G echogenic needle is advanced in-plane from cranial to caudal until the tip reaches the midpoint. After 1 mL normal saline confirms fascial separation, ropivacaine 0.375% 20 mL is injected in increments with intermittent aspiration every 5 mL. Correct placement is confirmed by fascial spread and pleural displacement on real-time ultrasound. Performed by a consultant anesthesiologist (regional analgesia).",[40],[57],"MTP Block",{"type":52,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Erector spinae plane (ESP) block","Performed under general anesthesia in the lateral decubitus position, at least 15 minutes before surgical incision. A linear transducer (10-15 MHz) is placed parasagittally 3 cm lateral to the midline at T4-T5, and the transverse process and the erector spinae muscle are identified. A 22G echogenic needle is advanced in-plane from caudal to cranial until the tip lies beneath the erector spinae muscle, just above the surface of the transverse process. A 1 mL normal saline injection produces the lift sign (erector spinae muscle lifted off the transverse process), then ropivacaine 0.375% 20 mL is injected gradually. Performed by a consultant anesthesiologist (regional analgesia).",[46],[46],[64,67],{"name":65,"affiliation":5,"role":66},"Tjokorda Gde Agung Senapathi, Professor","STUDY_CHAIR",{"name":68,"affiliation":5,"role":69},"Putu Herdita Sudiantara, Sp.An-TI","STUDY_DIRECTOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":25,"email":75},"Lalu Reza Aldira Akbar, MD","CONTACT","+6281337871680","aldeeraakbar@gmail.com",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RS Ngoerah","RECRUITING","Denpasar","Bali","80113","Indonesia","ID",{"type":86,"coordinates":87},"Point",[88,89],115.21667,-8.65,{"lat":89,"lon":88},[92],{"name":72,"role":73,"phone":74,"phoneExt":25,"email":75},{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Lalu Reza Aldira Akbar","Resident Physician, Anesthesiology","100659730","comparison-of-the-effectiveness-of-midpoint-transverse-process-to-pleura-mtp-block-and-erector-spinae-plane-esp-block-in-video-assisted-thoracoscopic-surgery-vats-at-rs-ngoerah-100659730",false,"NCT07868484","Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah","A Randomized, Double-Blind Controlled Trial Comparing the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah","MESA-VATS","Inclusion Criteria:\n\n* Adult patients scheduled for elective video-assisted thoracoscopic surgery (VATS) at RS Ngoerah\n* Age 18-65 years\n* ASA physical status I-III\n* Body mass index 18-30 kg\u002Fm2\n* Able to communicate well in Indonesian, understand the use of the Numerical Rating Scale, and complete the QoR-15 questionnaire\n* Willing to participate and has signed written informed consent\n\nExclusion Criteria:\n\n* Contraindication to regional anesthesia\n* Allergy to the drugs used (ropivacaine, fentanyl, paracetamol and\u002For ibuprofen)\n* Chronic chest pain for more than 2 months before surgery\n* Unable to be assessed with the Numerical Rating Scale and unable to operate the PCA device","ALL","18 Years","65 Years",{"count":109,"type":110},51,"ESTIMATED","INTERVENTIONAL",[113],"NA","This randomized, double-blind controlled trial compares two ultrasound-guided fascial plane blocks, the midpoint transverse process to pleura (MTP) block and the erector spinae plane (ESP) block, for postoperative analgesia in adults undergoing elective video-assisted thoracoscopic surgery (VATS) at RS Ngoerah, Denpasar, Indonesia. Both blocks are performed at the T4-T5 level after induction of general anesthesia and before skin incision, with a single injection of 20 mL ropivacaine 0.375%. Participants are randomly allocated, using block randomization and sealed opaque envelopes, to the MTP block group or the ESP block group. All participants receive the same general anesthesia, the same multimodal analgesia, and the same fentanyl patient-controlled analgesia (PCA) after surgery. The primary outcome is total fentanyl consumption via PCA in the first 24 hours after surgery. Secondary outcomes are numerical rating scale (NRS) pain scores at 0, 1, 2, 4, 6, 12 and 24 hours, time to first rescue analgesia, and Quality of Recovery-15 (QoR-15) score at 24 hours. All outcomes are assessed by the Acute Pain Service team, who are blinded to group allocation. The study tests whether the MTP block, which places local anesthetic closer to the thoracic paravertebral space, differs from the ESP block in these outcomes.",[116,117],"Pain","Postoperative Pain",[119,120,57,121,122,123,124,125,126,127,128],"Erector Spinae Plane Block","Midpoint Transverse Process to Pleura Block","ESP Block","Video-Assisted Thoracoscopic Surgery","VATS","Ropivacaine","Fentanyl","Patient-Controlled Analgesia","Quality of Recovery-15","Fascial Plane Block","2026-10-05",{"date":131,"type":132},"2026-10-09","ACTUAL",{"date":134,"type":132},"2026-06-04",{"date":136,"type":110},"2026-10-04",{"name":5,"class":6},1]