Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:22 AM
Study NCT ID:
NCT07479069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block for Pain Control After Open Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Opioid Consumption', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Assessed by the percentage of patients requiring rescue opioid analgesia. The need for rescue analgesia is determined by a Visual Analogue Score (VAS) greater than five'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Block'], 'conditions': ['Postoperative Pain', 'Open Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'his randomized controlled trial aims to evaluate the efficacy of the bilateral erector spinae plane (ESP) block in reducing postoperative opioid consumption in patients undergoing open abdominal surgeries under general anesthesia', 'detailedDescription': 'Patients undergoing abdominal surgeries experience severe postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating the analgesic effects and complications associated with the bilateral ESP block. The study involves 46 patients allocated into two groups using a lottery method: a control group receiving standard pain control treatment, and an erector spinae block group receiving a bilateral ESP block in addition to standard pain control treatment. Pain intensity will be evaluated using a visual analogue scale (VAS) at 4, 8, 12, and 24 hours after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology (ASA) stage I-II.\n* Scheduled for abdominal surgery due to any indication.\n\nExclusion Criteria:\n\n* History of Diabetes\n* History of neuropathic diseases\n* History of gastrointestinal bleeding, peptic ulcer, or inflammatory bowel disease\n* History of long-term nonsteroidal anti-inflammatory\n* History of chronic opioid analgesic use\n* History of severe hepatic or renal failure'}, 'identificationModule': {'nctId': 'NCT07479069', 'briefTitle': 'Erector Spinae Plane Block for Pain Control After Open Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Memorial Hospital'}, 'officialTitle': 'Effect of Bilateral Erector Spinae Plane Block on Postoperative Opioid Consumption in Open Abdominal Surgeries Under General Anaesthesia', 'orgStudyIdInfo': {'id': 'FMH-15/12/2025-IRB-1840'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients receiving standard pain control treatment. Postoperatively, patients receive 1000 mg of IV paracetamol every 6 hours. If a patient reports a Visual Analogue Score (VAS) exceeding five, they will receive rescue analgesia consisting of nalbuphine 4mg', 'interventionNames': ['Drug: Standard Postoperative Analgesia']}, {'type': 'EXPERIMENTAL', 'label': 'Erector Spinae Block Group', 'description': 'Patients receiving bilateral ESP block in addition to standard pain control treatment', 'interventionNames': ['Procedure: Bilateral Erector Spinae Plane (ESP) Block', 'Drug: Standard Postoperative Analgesia']}], 'interventions': [{'name': 'Bilateral Erector Spinae Plane (ESP) Block', 'type': 'PROCEDURE', 'description': 'Administered after the induction of general anesthesia and before the surgical incision. Local anesthetic (0.25% ropivacaine or 0.25% bupivacaine) will be injected for a total of 20-40 mL', 'armGroupLabels': ['Erector Spinae Block Group']}, {'name': 'Standard Postoperative Analgesia', 'type': 'DRUG', 'description': 'Patients receive 1000 mg of IV paracetamol every 6 hours postoperatively. If a patient experiences a Visual Analogue Score (VAS) of more than five at any time, they receive rescue analgesia in the form of nalbuphine 4mg', 'armGroupLabels': ['Control Group', 'Erector Spinae Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Department of Anesthesia, Fatima Memorial Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatima Majeed', 'investigatorAffiliation': 'Fatima Memorial Hospital'}}}}