Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT06826833
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESP Block for Postoperative Analgesia in URS Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010268', 'term': 'Parapsychology'}, {'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (Numeric Rating Scale - NRS)', 'timeFrame': '0, 2, 6, 12, 24 hours postoperatively.', 'description': 'The Numeric Rating Scale (NRS, 0-10) will be used to assess postoperative pain intensity. Participants will be asked to rate their pain on a scale from 0 to 10, where:\n\n* 0 = No pain\n* 10 = Worst possible pain'}], 'secondaryOutcomes': [{'measure': 'Total Opioid Consumption (IV PCA Morphine Equivalent)', 'timeFrame': 'From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.', 'description': 'Description: Total opioid consumption will be recorded in morphine milligram equivalents (MME) administered via IV patient-controlled analgesia (PCA).'}, {'measure': 'Postoperative Nausea and Vomiting (PONV)', 'timeFrame': 'From 0 hours (postoperatively) to 24 hours postoperatively, assessed at 0, 2, 6, 12, and 24 hours.', 'description': 'The incidence of postoperative nausea and vomiting (PONV) will be recorded, defined as nausea and/or vomiting requiring treatment with ondansetron IV.'}, {'measure': 'Pain-Free Duration', 'timeFrame': 'From the end of surgery until the first request for pain medication, assessed up to 24 hours postoperatively.', 'description': 'Pain-free duration is defined as the time from the end of surgery to the first request for analgesia (when the patient reports pain requiring medication).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Postoperative Pain Management', 'Nephrolithiasis']}, 'referencesModule': {'references': [{'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '33807296', 'type': 'BACKGROUND', 'citation': 'Bryniarski P, Bialka S, Kepinski M, Szelka-Urbanczyk A, Paradysz A, Misiolek H. Erector Spinae Plane Block for Perioperative Analgesia after Percutaneous Nephrolithotomy. Int J Environ Res Public Health. 2021 Mar 31;18(7):3625. doi: 10.3390/ijerph18073625.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1097/AAP.0000000000000451', 'label': 'Ref. 2'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether the erector spinae plane (ESP) block provides better pain relief after flexible ureterorenoscopy (URS) surgery compared to standard analgesia alone. Researchers want to know:\n\nDoes the ESP block reduce pain levels in the first 24 hours after surgery?\n\nDoes it lower the need for opioid pain medication?\n\nDoes it reduce the need for additional (rescue) pain treatment?\n\nDoes it decrease the likelihood of postoperative nausea and vomiting (PONV)?\n\nParticipants will be randomly placed into one of two groups:\n\nESP Block Group: Participants will receive an ESP block using 20 mL of 0.25% bupivacaine under ultrasound guidance before surgery.\n\nControl Group: Participants will receive standard pain management without a nerve block.\n\nAll participants will receive general anesthesia during surgery and multimodal pain management after surgery. Researchers will compare pain scores, opioid use, rescue analgesic needs, and the occurrence of nausea and vomiting between the two groups.', 'detailedDescription': 'Intervention Group (ESP Block): Patients will receive 20 mL of 0.25% bupivacaine (1:1 diluted with 0.5% bupivacaine) under ultrasound guidance at the T8-T10 level.\n\nControl Group: No block will be performed, and patients will receive standard postoperative multimodal analgesia.\n\nProcedure Description: The ESP block will be performed under sterile conditions with a high-frequency linear ultrasound probe. A 100-mm echogenic needle will be inserted in a cephalocaudal direction to deposit the local anesthetic deep to the erector spinae muscle at the transverse process level. The correct spread of the anesthetic will be confirmed via real-time ultrasound imaging.\n\nAll patients will receive standardized general anesthesia and multimodal analgesia.\n\nOutcome measures include postoperative pain (NRS), opioid consumption, rescue analgesia requirement, and postoperative nausea and vomiting (PONV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing elective flexible ureterorenoscopy (URS).\n\nAge: 18-65 years.\n\nASA I-II.\n\nWilling to participate and provide written informed consent.\n\nExclusion Criteria:\n\nBMI \\>35 kg/m².\n\nAllergy to local anesthetics.\n\nCoagulation disorders or use of anticoagulants.\n\nPatients requiring emergency surgery.\n\nPatients with infection at the ESP block site.'}, 'identificationModule': {'nctId': 'NCT06826833', 'acronym': 'ESPURS', 'briefTitle': 'ESP Block for Postoperative Analgesia in URS Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'Efficacy of Erector Spinae Plane Block in Flexible Ureterorenoscopy (URS) Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TNKU-URS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESP Block Group', 'description': 'A regional anesthesia technique in which 20 mL of 0.25% bupivacaine is injected under ultrasound guidance at the T8-T10 level to provide postoperative pain relief.', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) Block']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients will receive routine multimodal analgesia without an ESP block.'}], 'interventions': [{'name': 'Erector Spinae Plane (ESP) Block', 'type': 'PROCEDURE', 'description': 'A regional anesthesia technique in which 20 mL of 0.25% bupivacaine is injected under ultrasound guidance at the T8-T10 level to provide postoperative pain relief.', 'armGroupLabels': ['ESP Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Tekirdağ', 'country': 'Turkey (Türkiye)', 'facility': 'Tekirdağ Namık Kemal University Research Hospital', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}], 'overallOfficials': [{'name': 'Ayhan Şahin, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Namik Kemal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Onur Baran', 'investigatorAffiliation': 'Namik Kemal University'}}}}