Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 7:21 AM
Study NCT ID:
NCT06156657
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2023-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the anasthesiologist who perform postoperative pain will not know the group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2023-11-26', 'studyFirstSubmitQcDate': '2023-11-26', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain control', 'timeFrame': '9 months', 'description': 'by using VAS score'}], 'secondaryOutcomes': [{'measure': 'postoperative 24 hour opioid consumption', 'timeFrame': '9 months', 'description': 'collecting total doses of opioids consumed in the first 24 hours postoperative in cmparison to the other group'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': '9 months', 'description': 'recording incidence, frequency and severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subcostal TAP', 'laparoscopic', 'sleeve gastrectomy'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '25948166', 'type': 'BACKGROUND', 'citation': 'Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.'}, {'pmid': '20830871', 'type': 'BACKGROUND', 'citation': 'Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.'}, {'pmid': '26426576', 'type': 'BACKGROUND', 'citation': 'Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.'}, {'pmid': '24993433', 'type': 'BACKGROUND', 'citation': 'Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.'}]}, 'descriptionModule': {'briefSummary': 'many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block\n\nbut subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block', 'detailedDescription': 'Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks\n\nAs the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)\n\nThe ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions\n\nThe TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).\n\nThe lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-60 years\n* ASA Ι-ΙΙ\n* BMI \\>35\n\nExclusion Criteria:\n\n* Patient refusal.\n* Allergy to study drugs.\n* Infection at site of injection.'}, 'identificationModule': {'nctId': 'NCT06156657', 'acronym': 'TAP', 'briefTitle': 'Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Postoperative Efficacy of Subcostal TAP Block in Laparoscopic Sleeve Gastrectomy Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TAP block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP group', 'description': 'patients candidate for laparoscopic sleeve gastrectomy to receive GA and subcostal TAP block to control postoperative pain and minimize opioid consumption', 'interventionNames': ['Other: subcostal TAP block']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'healthy controls candidate for laparoscopic sleeve gastrectomy to receive GA only opioids were used'}], 'interventions': [{'name': 'subcostal TAP block', 'type': 'OTHER', 'description': 'Comparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy', 'armGroupLabels': ['TAP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11811', 'city': 'Cairo', 'state': 'Naser City', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Selim, director', 'role': 'CONTACT', 'email': 'info@azhar.edu.eg', 'phone': '0020222611404'}], 'facility': 'Al Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ismail M Ahmed, prof', 'role': 'CONTACT', 'email': 'ismailabdelgawad.623@azhar.edu.eg', 'phone': '00201117310053'}, {'name': 'Khaled Elsheshtawy M Sherif, lecturer', 'role': 'CONTACT', 'email': 'khalkedsherif2@gmail.com', 'phone': '00201064819857'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD are planned to be coded for privacy protection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Ismail Mohamed Abdelgawad Ahmed', 'investigatorAffiliation': 'Al-Azhar University'}}}}