Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-29 @ 5:26 PM
Study NCT ID:
NCT07113600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Both blocks will be performed after induction of general anesthesia'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated with a 1:1 allocation ratio into two groups in a parallel manner:\n\n* Group A(n=29): Patients will receive bilateral ESP block using 20 ml bupivacaine 0.25% on each side.\n* Group B(n=29): Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20 ml bupivacaine 0.25% on each side.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-02', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total post-operative opioid consumption', 'timeFrame': 'The first 12 postoperative hours', 'description': 'The total Rescue analgesia boluses of morphine ( 0.1mg/kg if the VAS exceeded 3 \\& repeated until the VAS dropped below 3.'}], 'primaryOutcomes': [{'measure': 'The time to first call for analgesia.', 'timeFrame': 'The first 12 postoperative hours', 'description': 'The period of time starting from extubation until the patient asks for analgesia in hours.'}], 'secondaryOutcomes': [{'measure': 'postoperative pain score', 'timeFrame': 'VAS was assessed at 0, 2, 6, and 12 hours postoperatively.', 'description': 'Visual analog scale (0-100 mm)'}, {'measure': 'intraoperative hemodynamic changes', 'timeFrame': 'Operative time', 'description': 'Increase in heart rate(beat/min) or systolic blood pressure(mmHg) more than 20% of the baseline , hypotension (defined as a decrease in mean arterial pressure \\> 25% from the baseline value or systolic arterial pressure \\< 100 mmHg),'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Humans', 'Female', 'Anesthesia, Conduction', 'Ultrasonography', 'Nerve Block', 'Pain, Postoperative', 'Ultrasonography, Interventional'], 'conditions': ['Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia.\n\nOne group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block).\n\nThe other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ).\n\nResearchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.', 'detailedDescription': 'The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.\n\nAbdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.\n\nThe ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.\n\nThe aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients above the age of 35 years.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n\nExclusion Criteria:\n\n* Patient refusal.\n* History of allergy or intolerance to study medications.\n* Chronic opioid use (\\>3 months).\n* Severe renal or hepatic impairment.\n* Patients with coagulopathy disorders.\n* Infection at injection sites.'}, 'identificationModule': {'nctId': 'NCT07113600', 'briefTitle': 'Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy', 'orgStudyIdInfo': {'id': 'N-119_2023/MSc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB', 'description': 'Patients will receive bilateral Erector Spinae Plane block using 20ml bupivacaine 0.25% on each side.', 'interventionNames': ['Other: Nerve Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ilioinguinal/iliohypogastric', 'description': 'Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20ml bupivacaine 0.25% on each side.', 'interventionNames': ['Other: Nerve Block']}], 'interventions': [{'name': 'Nerve Block', 'type': 'OTHER', 'description': 'Ilioinguinal/ Iliohypogastric nerve block:\n\nIn the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane.\n\nA echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is injected gradually close to the nerves.\n\nErector spinae plane block:\n\nIn a lateral position, the erector spinae is visualized about 3 cm lateral to T7-T9 spinous processes on the target side. A echogenic needle (50 mm/22 gauge) is advanced in a cephalad to caudad direction until the tip reaches the plane deep to the erector spinae muscle immediately lateral to the transverse process. A 20 ml bupivacaine 0.25% is injected gradually into this plane.', 'armGroupLabels': ['ESPB', 'Ilioinguinal/iliohypogastric']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Of anesthesia', 'investigatorFullName': 'Mai Ahmed Ali Mohamed El-sayed', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}