[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657579":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":57,"studyPopulation":45,"armGroups":58,"interventions":76,"overallOfficials":90,"centralContacts":94,"locations":101,"responsibleParty":114,"collaborators":45,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":45,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":45,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":151,"whyStopped":45,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Medipol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Total rescue tramadol consumption during the first 24 postoperative hours","Cumulative dose of intravenous tramadol administered as rescue analgesia (milligrams) during the first 24 hours after extubation. Rescue tramadol 0.5-1 mg\u002Fkg intravenously is administered whenever the numeric rating scale (NRS) score is 4 or higher.","0 to 24 hours after extubation",[14,18,21,24,27,30,33,37,41],{"measure":15,"description":16,"timeFrame":17},"Pain intensity at rest measured with the Numeric Rating Scale (NRS)","Pain at rest rated by the participant on an 11-point numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain.","1, 3, 6, 12, 18 and 24 hours after extubation",{"measure":19,"description":20,"timeFrame":17},"Pain intensity on movement measured with the Numeric Rating Scale (NRS)","Pain during movement (coughing or sitting up) rated by the participant on an 11-point numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain.",{"measure":22,"description":23,"timeFrame":12},"Proportion of participants requiring rescue analgesia","Number and percentage of participants in each group who receive at least one dose of rescue intravenous tramadol during the first 24 postoperative hours.",{"measure":25,"description":26,"timeFrame":12},"Time to first rescue analgesic request","Time in minutes from extubation to administration of the first dose of rescue intravenous tramadol. Participants who require no rescue analgesia are censored at 24 hours.",{"measure":28,"description":29,"timeFrame":12},"Incidence of postoperative nausea and vomiting","Number and percentage of participants with at least one episode of nausea and of vomiting during the first 24 postoperative hours.",{"measure":31,"description":32,"timeFrame":12},"Incidence of pruritus","Number and percentage of participants reporting pruritus during the first 24 postoperative hours.",{"measure":34,"description":35,"timeFrame":36},"Incidence of block-related complications and signs of local anesthetic systemic toxicity (LAST)","Number and percentage of participants with block-related complications (haematoma, intraperitoneal or vascular puncture, pneumothorax, infection at the injection site) or clinical signs of local anesthetic systemic toxicity (perioral numbness, tinnitus, altered mental status, seizure, arrhythmia, cardiovascular collapse).","From performance of the block until 24 hours after extubation",{"measure":38,"description":39,"timeFrame":40},"Patient satisfaction with postoperative analgesia","Satisfaction with postoperative pain management rated by the participant on a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction.","At 24 hours after extubation",{"measure":42,"description":43,"timeFrame":44},"Length of hospital stay","Time in hours from the end of surgery until hospital discharge.","From end of surgery until hospital discharge, assessed up to 7 days",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","Three parallel groups randomly allocated in a 1:1:1 ratio; each participant receives a single allocated intervention at the end of surgery.","TREATMENT",{"masking":52,"maskingDescription":53,"whoMasked":54},"DOUBLE","All interventions are performed under general anesthesia, so participants are unaware of their group allocation. Study solutions for the two block groups are prepared by an anesthesiologist not otherwise involved in the trial and supplied in identical, indistinguishable syringes labelled only with the randomization number; because both solutions are clear, the anesthesiologist performing the block is also blinded to the bupivacaine concentration. All postoperative assessments are performed by an anesthesiologist blinded to group allocation who takes no part in the intervention. The operating-room team cannot be blinded to the presence or absence of a block, and therefore cannot be blinded to the control group.",[55,56],"PARTICIPANT","OUTCOMES_ASSESSOR","Design. This is a prospective, randomized, double-blind (participant and outcomes assessor), controlled, single-centre trial to be conducted at Istanbul Medipol University Mega Hospital Complex after approval by the institutional ethics committee, in accordance with the Declaration of Helsinki, and registered prospectively on ClinicalTrials.gov. Written informed consent will be obtained from all participants.\n\nRandomization and blinding. Before transfer to the operating room, patients will be allocated in a 1:1:1 ratio to one of three groups using a sequence generated with the Research Randomizer program. Study solutions for the two block groups will be prepared by an anesthesiologist not otherwise involved in the trial and supplied in identical, indistinguishable syringes labelled only with the randomization number (Group Y: 30 mL of 0.5% bupivacaine + 30 mL of 0.9% saline; Group D: 15 mL of 0.5% bupivacaine + 45 mL of 0.9% saline). As both solutions are clear, the anesthesiologist performing the block is also blinded to the concentration. All procedures are performed under general anesthesia, so participants are unaware of their allocation. All postoperative assessments will be performed by an anesthesiologist blinded to group allocation who takes no part in the intervention.\n\nGroups. Group Y receives bilateral rectus intercostal fascial plane block (RIFPB) with 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total). Group D receives bilateral RIFPB with 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). Group K (control) receives no block and is managed with the institution's routine analgesic protocol, including port-site infiltration with 30 mL of 0.25% bupivacaine performed by the surgical team. Total volume is held constant in both block groups; only the administered dose differs. To allow the isolated effect of the block to be assessed, port-site infiltration is not performed in the block groups. The total bupivacaine dose will not exceed 2.5 mg\u002Fkg in any group.\n\nAnesthesia and surgery. After premedication with 2 mg of intravenous midazolam, general anesthesia will be induced with propofol (2-2.5 mg\u002Fkg), fentanyl (1-1.5 mcg\u002Fkg) and rocuronium (0.6 mg\u002Fkg), and maintained with sevoflurane and a remifentanil infusion (0.05-2 mcg\u002Fkg\u002Fmin). Surgery will be performed by the same team using the conventional four-port technique. All patients will receive 4 mg of ondansetron for nausea prophylaxis, and 400 mg of ibuprofen and 100 mg of tramadol approximately 20 minutes before skin closure.\n\nBlock technique. The block will be performed bilaterally at the end of surgery, before extubation, with the patient supine and under general anesthesia. Using a high-frequency linear ultrasound probe (11-12 MHz) and an 80 mm block needle, the probe will be placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages. After hydrodissection with 5 mL of saline using an in-plane technique, 30 mL of the study solution will be injected on each side. Aspiration will be performed before injection, the drug will be given in fractionated doses, patients will be continuously monitored, and 20% lipid emulsion will be immediately available in the operating room.\n\nPostoperative analgesia and assessment. All patients will receive 400 mg of intravenous ibuprofen three times daily. Pain will be assessed with the numeric rating scale (NRS, 0-10) at rest and on movement at 1, 3, 6, 12, 18 and 24 hours postoperatively. Rescue analgesia with 0.5-1 mg\u002Fkg of intravenous tramadol will be given whenever the NRS score is 4 or higher.\n\nWithdrawal. Patients converted to open surgery after randomization will be excluded from the analysis.\n\nStatistical analysis. Data will be analysed on an intention-to-treat basis. Normality of distribution will be assessed with the Shapiro-Wilk test. Normally distributed continuous variables will be compared among the three groups using one-way analysis of variance (ANOVA) with post hoc Bonferroni correction, and non-normally distributed variables using the Kruskal-Wallis test with post hoc Dunn correction. Categorical variables will be compared with the chi-square or Fisher exact test. Repeated NRS measurements will be analysed with repeated-measures ANOVA or the Friedman test as appropriate. A two-sided p value below 0.05 will be considered statistically significant.\n\nEthical considerations. Patients in the control group will not be deprived of analgesic treatment; they will receive the institution's routine port-site infiltration and standard multimodal analgesia protocol, and rescue analgesia whenever the NRS score is 4 or higher. Both bupivacaine doses compared are within the safe range, and the total dose is halved in the low-concentration group. Patient data will be stored in coded form. The study has no financial support and the investigators declare no conflict of interest.",[59,65,70],{"label":60,"type":61,"description":62,"interventionNames":63},"Group Y - Recto-intercostal fascial plane block with 0.25% bupivacaine","EXPERIMENTAL","Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total). Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg\u002Fkg whenever the numeric rating scale (NRS) score is 4 or higher.",[64],"Drug: Bupivacaine 0.25% - rectus intercostal fascial plane block",{"label":66,"type":61,"description":67,"interventionNames":68},"Group D - Recto-intercostal fascial plane block with 0.125% bupivacaine","Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The injected volume is identical to that of Group Y; only the administered dose differs. Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg\u002Fkg whenever the numeric rating scale (NRS) score is 4 or higher.",[69],"Drug: Bupivacaine 0.125% - rectus intercostal fascial plane block",{"label":71,"type":72,"description":73,"interventionNames":74},"Group K - Control (port-site infiltration)","ACTIVE_COMPARATOR","No fascial plane block is performed. Patients are managed with the institution's routine analgesic protocol, including port-site infiltration with 30 mL of 0.25% bupivacaine performed by the surgical team. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg\u002Fkg whenever the numeric rating scale (NRS) score is 4 or higher.",[75],"Drug: Bupivacaine 0.25% - port-site infiltration",[77,82,86],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":45},"DRUG","Bupivacaine 0.25% - rectus intercostal fascial plane block","Bilateral ultrasound-guided rectus intercostal fascial plane block (RIFPB) with a high-frequency linear probe (11-12 MHz) and an 80 mm block needle. The probe is placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages; after in-plane hydrodissection with 5 mL of saline, 30 mL of 0.25% bupivacaine is injected on each side (60 mL, 150 mg in total). Aspiration is performed before injection and the drug is given in fractionated doses.",[60],{"type":78,"name":83,"description":84,"armGroupLabels":85,"otherNames":45},"Bupivacaine 0.125% - rectus intercostal fascial plane block","Bilateral ultrasound-guided rectus intercostal fascial plane block (RIFPB) performed with the identical technique and the identical volume as in Group Y, using 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The solution is prepared by diluting 15 mL of 0.5% bupivacaine with 45 mL of 0.9% saline.",[66],{"type":78,"name":87,"description":88,"armGroupLabels":89,"otherNames":45},"Bupivacaine 0.25% - port-site infiltration","Routine institutional practice: infiltration of the laparoscopic port sites by the surgical team with 30 mL of 0.25% bupivacaine (75 mg). No fascial plane block is performed.",[71],[91],{"name":92,"affiliation":5,"role":93},"Burak Ömür","PRINCIPAL_INVESTIGATOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":45,"email":99},"Burak Ömür, MD","CONTACT","+905056215056","bomur@medipol.edu.tr",{"name":96,"role":97,"phone":98,"phoneExt":45,"email":45},[102],{"facility":103,"status":45,"city":104,"state":45,"zip":45,"country":105,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Istanbul Medipol University Mega Hospital Complex, Department of Anesthesiology and Reanimation","Istanbul","Turkey (Türkiye)",{"type":107,"coordinates":108},"Point",[109,110],28.94966,41.01384,{"lat":110,"lon":109},[113],{"name":96,"role":97,"phone":98,"phoneExt":45,"email":99},{"type":93,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Burak Omur","Assistant Professor of Anesthesiology and Reanimation","100657579","two-bupivacaine-concentrations-for-rectus-intercostal-fascial-plane-block-after-laparoscopic-cholecystectomy-100657579",false,"NCT07841951","Two Bupivacaine Concentrations for Rectus Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy","Effect of Two Different Bupivacaine Concentrations in Rectus Intercostal Fascial Plane Block on Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized, Controlled, Double-Blind Trial","Inclusion Criteria:\n\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia\n* Aged between 18 and 65 years\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Body weight above 60 kg\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to local anesthetics or opioids\n* Coagulopathy or ongoing anticoagulant therapy\n* Infection at the site of block injection\n* Alcohol or substance dependence, or chronic opioid use\n* Pregnancy or lactation\n* Advanced hepatic or renal failure\n* Any condition preventing the participant from understanding and using the - numeric rating scale\n* Refusal to participate","ALL","18 Years","75 Years",{"count":128,"type":129},90,"ESTIMATED","INTERVENTIONAL",[132],"NA","Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The rectus intercostal fascial plane block (RIFPB) is a recently described technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the sixth to ninth thoracic (T6-T9) thoracoabdominal nerves.\n\nIn the investigators' previous randomized controlled trial, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and whether lower doses provide comparable analgesia remains unknown. Because fascial plane blocks depend on local anesthetic spread, large volumes are preferred, increasing the total dose and the risk of local anesthetic systemic toxicity (LAST); lowering the concentration as volume increases has therefore been recommended. Equal-volume studies of transversus abdominis plane and erector spinae plane blocks suggest that lower concentrations provide comparable analgesia, but no study has compared concentrations for RIFPB.\n\nThis trial will compare, at a fixed volume of 30 mL per side (60 mL in total), bilateral RIFPB with 0.25% bupivacaine, bilateral RIFPB with 0.125% bupivacaine, and routine port-site infiltration without a block (control) in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio.\n\nThe primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes include numeric rating scale (NRS) pain scores at rest and on movement, the need for and time to first rescue analgesia, nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay.\n\nThe investigators hypothesize that RIFPB at either concentration will reduce analgesic consumption and pain scores compared with control, and that the lower concentration will provide comparable analgesia while halving the total bupivacaine dose (75 mg instead of 150 mg), thereby reducing the risk of LAST.",[135,136,137,138],"Postoperative Pain","Acute Pain","Cholelithiasis","Anesthesia",[140,141,142,143,144,145,146,147,148,149,150],"rectus intercostal fascial plane block","RIFPB","fascial plane block","bupivacaine","local anesthetic concentration","postoperative analgesia","laparoscopic cholecystectomy","opioid consumption","regional anesthesia","ultrasound-guided nerve block","local anesthetic systemic toxicity","NOT_YET_RECRUITING","2026-09-30",{"date":154,"type":155},"2026-10-05","ACTUAL",{"date":154,"type":129},{"date":158,"type":129},"2027-04-30",{"name":5,"class":6},1]