[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607342":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":65,"studyPopulation":57,"armGroups":66,"interventions":83,"overallOfficials":93,"centralContacts":98,"locations":109,"responsibleParty":138,"collaborators":57,"id":141,"slug":57,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":57,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":57,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":112,"whyStopped":57,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Fayoum University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Total opioid consumption","Post operative nalbuphine used in the first 24 hours in milligrams","Up to 24 hours after surgery",[14,18,22,26,30,33,37,41,45],{"measure":15,"description":16,"timeFrame":17},"Intraoperative Fentanyl consumption","Total fentanyl in milligrams","From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours",{"measure":19,"description":20,"timeFrame":21},"Time needed to complete the block","In minutes","From start of block procedure up to 1 hour",{"measure":23,"description":24,"timeFrame":25},"Sensory block distribution level (pin-prick test)","sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region.","after 30 minuets from the block maneuver bilaterally",{"measure":27,"description":28,"timeFrame":29},"Heart rate","Heart rate (HR) recorded intra and post operative","Upon arrival to Operating Room until 24 hours postoperative",{"measure":31,"description":32,"timeFrame":29},"Blood pressure","Mean Arterial Pressure (MAP)",{"measure":34,"description":35,"timeFrame":36},"Postoperative pain scores by Visual Analogue Scale (VAS)","score from 0 to 10 where 0 indicates no pain and 10 indicates the worst imaginable pain","From patient discharge to postoperative anesthesia care unit 24 hours postoperatively",{"measure":38,"description":39,"timeFrame":40},"Rescue analgesia","Time to first request of rescue analgesia","Upon recovery from General anesthesia up to 24 h postoperatively",{"measure":42,"description":43,"timeFrame":44},"Incidence of opioid-related side effects","Assessment of each patient looking for any of the side effects of opioids as nausea, vomiting, sedation.","From induction of anesthesia up to 24 h postoperatively",{"measure":46,"description":47,"timeFrame":48},"Incidence of Block-related side effects","any Block-related side effects as Local anesthetic systemic toxicity, bleeding, pneumothorax, local infection.","From the time just after giving the block up to 24 h postoperatively",[50],{"measure":51,"description":52,"timeFrame":53},"Quality of recovery (QoR-15)","scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery.","At 24 hours postoperatively",{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":57,"timePerspective":57,"maskingInfo":59},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":60,"maskingDescription":57,"whoMasked":61},"TRIPLE",[62,63,64],"CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement, this prospective, randomized, double-blinded, controlled clinical trial will be conducted at Fayoum University Hospital (FUH) starting from October 2025 until the sample size is reached.\n\nAfter obtaining approval from the local institutional ethics committee at Fayoum University Hospital (FUH) and registering the trial on ClinicalTrials.gov, all patients scheduled for elective cholecystectomy at FUH will sign a detailed informed consent form after fulfilling the eligibility criteria.\n\nPatients will be randomly assigned to three equal groups with an allocation ratio of 1:1:1 (n=35) using computer-generated random numbers that will be sealed in a closed opaque envelope, opened by the anesthesiologist responsible for administering the ultrasound-guided block preoperatively\n\n* Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.\n* Group B (ESP Block Group): Patients will receive bilateral ESP blocks.\n* Group C (Control Group): patients will not receive any block, only standard care.\n\nPreoperatively, all patients will be assessed and investigated by complete blood count, Prothrombin time and concentration, kidney and liver functions. Additional investigations, such as serum electrolytes, ECG, ECHO, etc., will be ordered upon individual patient assessment.\n\nAll blocks will be performed by an anesthesiologist experienced in regional blocks preoperatively in a separate block room under strict aseptic conditions using ultrasound guidance after applying standard monitoring (pulse oximetry, non-invasive blood pressure, and electrocardiogram) and administering a sedative dose of intravenous midazolam (0.03 mg\u002Fkg).\n\nFor both groups A and B, sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region. If no sensory loss is observed, the patient will be excluded from the study.\n\nAll patients will then be transferred to the operating room, handed over to the attending anesthesiologist who is blinded to group allocation and is responsible for further patient management. standard monitoring will be reapplied, and then general anesthesia will be induced using propofol (2 mg\u002Fkg), atracurium (0.5 mg\u002Fkg), and fentanyl (2 μg\u002Fkg). Anesthesia will be maintained with intermittent intravenous atracurium (0.1 mg\u002Fkg boluses) and an isoflurane inhalation in an oxygen and air mixture. An intravenous Ketorolac (30 mg), Nalbuphine (10 mg), and Ondansetron 8 mg will be administered approximately 30 minutes before the end of the operation.\n\nAfter discharge to the ward, paracetamol 1g \u002F8 hours and ketorolac 30 mg\u002F12 hours will be administered to all patients. Both static (at rest) and dynamic (with movement) visual analogue scale (VAS) will be assessed at 1,2, 4, 6, 12, and 24 hours (where 0 denotes no pain, and 10 represents the most intense pain ever experienced), and if the VAS score is equal to or higher than 4, a rescue analgesic dose of nalbuphine 5 mg will be administered.",[67,73,79],{"label":68,"type":69,"description":70,"interventionNames":71},"EXORA block group","EXPERIMENTAL","Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.",[72],"Procedure: EXORA block",{"label":74,"type":75,"description":76,"interventionNames":77},"ESP block group","ACTIVE_COMPARATOR","Group B (ESP Block Group): Patients will receive bilateral ESP blocks.",[78],"Procedure: Erector Spinae Plane block",{"label":80,"type":81,"description":82,"interventionNames":57},"control group","NO_INTERVENTION","Group C (Control Group): patients will not receive any block, only standard care.",[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":57},"PROCEDURE","EXORA block","in a supine position, a linear Ultrasound probe (L6-12 RS linear array transducer (6-12 MHz) on GE Healthcare Logiq P7, made in Korea) will be sagittally applied at the parasternal line, lateral to the sternum and xiphoid process. The probe will be manipulated craniocaudally to identify the 6th, 7th, and 8th costal cartilages. At the level of the 8th costal cartilage, a transverse orientation will be used to visualize the rectus abdominis muscle and the costal cartilage beneath. An 88-mm, 22-gauge needle will be directed in-plane from medial to lateral. After confirming the needle position below the rectus abdominis muscle using 4 ml isotonic saline as a hydro-dissection, 25 ml of plain bupivacaine 0.25% concentration will be injected. the spread of the local anesthetic is to be observed to advance laterally under the external oblique muscle and medially under the rectus muscle. The same procedure will be repeated on the other side.",[68],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":57},"Erector Spinae Plane block","in a right lateral position, the linear Ultrasound probe will be placed vertically 3 cm lateral to the midline at the level of the 7th thoracic spinal process, identifying the T7 transverse process, and the overlying erector spinae (ES) muscle. An 88-mm, 22-gauge needle will be advanced craniocaudally in-plane until hitting the T7 transverse process. After using hydro-dissection with 4 ml of isotonic saline to confirm the correct needle position, 25 ml of 0.25% bupivacaine will be administered below the erector spinae muscle. The same procedure will be repeated on the other side.",[74],[94],{"name":95,"affiliation":96,"role":97},"Mohamed A Hamed, MD","Faculty of medicine, Fayoum university","PRINCIPAL_INVESTIGATOR",[99,105],{"name":100,"role":101,"phone":102,"phoneExt":103,"email":104},"Khaled M Sayed, Bch","CONTACT","1065444158","+20","khaledm191170@gmail.com",{"name":106,"role":101,"phone":107,"phoneExt":103,"email":108},"Mohamed H Ragab, MD","1090050298","mhr02@fayoum.edu.eg",[110],{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Fayoum University hospital","RECRUITING","El Fayoum Qesm","Faiyum Governorate","63514","Egypt","EG",{"type":119,"coordinates":120},"Point",[121,122],30.83333,29.31667,{"lat":122,"lon":121},[125,128,129,131,134,136],{"name":95,"role":101,"phone":126,"phoneExt":103,"email":127},"1010509736","mah07@fayoum.edu.eg",{"name":106,"role":101,"phone":107,"phoneExt":103,"email":108},{"name":130,"role":97,"phone":57,"phoneExt":57,"email":57},"Mohamed A Hamed",{"name":132,"role":133,"phone":57,"phoneExt":57,"email":57},"Mohamed A Shawky","SUB_INVESTIGATOR",{"name":135,"role":133,"phone":57,"phoneExt":57,"email":57},"Mohamed H Ragab",{"name":137,"role":133,"phone":57,"phoneExt":57,"email":57},"Khaled M Sayed",{"type":97,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Mohamed Ahmed Hamed","Professor of Anesthesiology","100607342",false,"NCT07187310","EXORA vs ESP Blocks in Laparoscopic Cholecystectomy","The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia","Inclusion Criteria:\n\n* Elective laparoscopic cholecystectomy\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* Known allergy to local anesthetics\n* Chronic pain or regular opioid use\n* Coagulopathy or anticoagulant therapy\n* Local infection at the block site\n* BMI more than 35 kg\u002Fm2\n* Neurological or psychiatric disorders\n* Refusal to participate","ALL","18 Years","65 Years",{"count":151,"type":152},114,"ESTIMATED","INTERVENTIONAL",[155],"NA","Laparoscopic cholecystectomy is still considered the gold standard for the surgical management of gallbladder disease due to its minimally invasive nature, shorter recovery time, and reduced postoperative complications. Despite these advantages, patients frequently experience moderate to severe postoperative pain, particularly in the early postoperative period, which can impede recovery, delay mobilization, and increase opioid consumption. Excessive opioid use after laparoscopic cholecystectomy is associated with several drawbacks, including nausea, vomiting, sedation, and delayed recovery. It also increases the risk of respiratory depression, especially in vulnerable patients, and may contribute to long-term opioid dependence. These risks highlight the importance of opioid-sparing strategies such as regional anesthesia techniques to improve patient outcomes and enhance recovery. Regional anesthesia techniques have emerged as essential components of multimodal analgesia strategies in abdominal surgeries. Among them, the Erector Spinae Plane (ESP) Block has gained popularity due to its relative ease of administration and favorable safety profile.\n\nRecently, a novel fascial plane block known as the EXORA block has been introduced as a promising alternative for abdominal wall analgesia. This block, which targets a different anatomical plane, is postulated to provide comparable or superior analgesic efficacy to traditional methods while maintaining safety and simplicity in execution. Given the ongoing pursuit of optimal analgesia with minimal side effects, it is essential to compare emerging techniques, such as the EXORA block, with established methods like the ESP block.\n\nThe authors hypothesize that the EXORA and the ESP blocks provide superior postoperative analgesia compared to controls in patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is superior to that of the ESP block.",[158],"Postoperative Pain",[86,160,161,162],"Erector spinae Plain block","Regional Anesthesia for Laparoscopic Cholecystectomy","Postoperative pain management in abdominal surgeries","2026-05-30",{"date":165,"type":166},"2026-06-02","ACTUAL",{"date":168,"type":166},"2025-12-30",{"date":170,"type":152},"2026-08-01",{"name":5,"class":6},1]