Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-05 @ 2:03 PM
Study NCT ID:
NCT06584695
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-08-31', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '24 hours after surgery', 'description': 'Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was \\> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Mean arterial pressure', 'timeFrame': 'Till the end of surgery (up to 2hours)', 'description': 'Mean arterial pressure will be recorded intraoperative till the end of surgery.'}, {'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (up to 2hours)', 'description': 'Heart rate will be recorded intraoperative till the end of surgery.'}, {'measure': 'Opioids consumption', 'timeFrame': '24 hours after surgery', 'description': 'Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). when the (NRS) was \\> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.'}, {'measure': 'Morphine consumption', 'timeFrame': '24 hours after surgery.', 'description': 'When the numeric rating scale (NRS) was \\>4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.\n\nEach patient will be instructed about postoperative pain assessment with the NRS score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable").NRS will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery.'}, {'measure': 'Time to rescue analgesia.', 'timeFrame': '24 hours after surgery', 'description': 'Time to rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.'}, {'measure': 'Incidence of complications', 'timeFrame': '24 hours after surgery', 'description': 'Incidence of complications will be recorded such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesic Efficacy', 'External Oblique Intercostal Block', 'Subcostal Transversus Abdominis Plane Block', 'Open', 'Nephrectomy']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.', 'detailedDescription': 'Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.\n\nRegional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.\n\nAlthough abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.\n\nStudies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.\n\nThe external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (18-65) year.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) class II and III.\n* Cancer patients candidate for open nephrectomy .\n\nExclusion Criteria:\n\n* Patient refusal.\n* Skin lesions or infection at the site of proposed needle insertion.\n* Cognitive disorders.\n* History of psychiatric disorders or drug abuse.\n* Patients allergic to medication used.\n* ASA class IV.\n* Coagulopathy.\n* Body mass index (BMI) more than 35.'}, 'identificationModule': {'nctId': 'NCT06584695', 'briefTitle': 'Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Analgesic Efficacy of External Oblique Intercostal Block Versus Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy', 'orgStudyIdInfo': {'id': 'AP2407-201-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transversus abdominis plane group', 'description': 'patients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block', 'interventionNames': ['Drug: Transversus abdominis plane block']}, {'type': 'EXPERIMENTAL', 'label': 'External oblique intercostal group', 'description': 'Patients will receive unilateral ultrasound-guided external oblique intercostal block', 'interventionNames': ['Drug: External Oblique Intercostal Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.', 'interventionNames': ['Drug: Control group']}], 'interventions': [{'name': 'Transversus abdominis plane block', 'type': 'DRUG', 'description': 'Patients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles along the subcostal line.', 'armGroupLabels': ['Transversus abdominis plane group']}, {'name': 'External Oblique Intercostal Plane Block', 'type': 'DRUG', 'description': 'Patients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique with a 22G, 80 mm block needle will be used to inject 25 ml of 0.25% bupivacaine into the external oblique intercostal plane.', 'armGroupLabels': ['External oblique intercostal group']}, {'name': 'Control group', 'type': 'DRUG', 'description': 'Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.\n\nGeneral anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Abdelbaset, Master', 'role': 'CONTACT', 'email': 'ahmedabdelbaset500@gmail.com', 'phone': '00201144329865'}, {'name': 'Khaled Elsamahy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Walaa Youssef, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sayed M Abed, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Asmaa E Khalil, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed A Abdelbaset, Master', 'role': 'CONTACT', 'email': 'ahmedabdelbaset500@gmail.com', 'phone': '00201144329865'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist of Anesthesia, Surgical Intensive Care & Pain Relief', 'investigatorFullName': 'Ahmed Abdelbaset Mostafa', 'investigatorAffiliation': 'Cairo University'}}}}