Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-02 @ 6:56 AM
Study NCT ID:
NCT06411795
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004091', 'term': 'Hydromorphone'}, {'id': 'D007479', 'term': 'Iopamidol'}, {'id': 'D013662', 'term': 'Tea'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D019047', 'term': 'Phantoms, Imaging'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients and providers will not be blinded to the analgesic technique'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Milligram morphine equivalents (MME)', 'timeFrame': 'Up to 96 hours after open pancreatoduodenectomy', 'description': 'Opioid consumption will be evaluated as a non-inferiority hypothesis using a two-sample t-test to compare the groups, with the conclusion of statistical significance being drawn from the corresponding confidence interval for the differences in mean MMEs between groups.'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'At 24, 48, 72 and 96 hours', 'description': 'Pain scores at rest and with movement will be assessed using a numeric rating scale pain scores where 0 is no pain and 10 is worst pain.'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 7 days after surgery', 'description': 'Average hospital length of stay'}, {'measure': 'Opioid consumption', 'timeFrame': '96 hours', 'description': 'Average Opioid consumption (milligrams)'}, {'measure': 'Time to return of bowel function', 'timeFrame': 'Up to 7 days after surgery', 'description': 'Average time to return of bowel function will be measured by first oral intake.'}, {'measure': 'Incidence of nausea, vomiting, hypotension and pruritis', 'timeFrame': 'At 24 hours, 48 hours, 72 hours and 96 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Duodenal Neoplasm', 'Pancreatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. Epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia (TEA) for patients undergoing pancreatoduodenectomy.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP EPIDURAL (E): Prior to pancreatoduodenectomy, patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively. Patients also receive iopamidol via epidural and undergo x-ray imaging on study.\n\nGROUP RECTUS SHEATH (RS): Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study\n\nExclusion Criteria:\n\n* Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)\n* Patients with chronic opioid use (at least 30 milligram morphine equivalents \\[MME\\] for 3 or more weeks leading up to surgery)\n* Patients unable to understand the quality of recovery survey intellectual barriers. This will be determined by the primary investigator/attending anesthesiologist's discretion\n* Patient refusal and those who have opted out of research\n* Pregnant patients - will be assessed through review of the medical record"}, 'identificationModule': {'nctId': 'NCT06411795', 'briefTitle': 'Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial', 'orgStudyIdInfo': {'id': 'ANES-2023-31918'}, 'secondaryIdInfos': [{'id': 'NCI-2024-02287', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ANES-2023-31918', 'type': 'OTHER', 'domain': 'University of Minnesota/Masonic Cancer Center'}, {'id': 'P30CA077598', 'link': 'https://reporter.nih.gov/quickSearch/P30CA077598', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E (TEA)', 'description': 'Prior to pancreatoduodenectomy, patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively. Patients also receive iopamidol via epidural and undergo x-ray imaging on study.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Hydromorphone', 'Drug: Iopamidol', 'Other: Medical Chart Review', 'Other: Questionnaire Administration', 'Drug: Thoracic Epidural Analgesia', 'Procedure: X-Ray Imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Group RS (rectus sheath block)', 'description': 'Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Liposomal Bupivacaine', 'Other: Medical Chart Review', 'Other: Questionnaire Administration', 'Procedure: Ultrasound Imaging']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['AH 250'], 'description': 'Given via epidural and injection', 'armGroupLabels': ['Group E (TEA)', 'Group RS (rectus sheath block)']}, {'name': 'Hydromorphone', 'type': 'DRUG', 'otherNames': ['(-)-Hydromorphone', 'Dihydromorphinone', 'Hydromorphon'], 'description': 'Given via epidural', 'armGroupLabels': ['Group E (TEA)']}, {'name': 'Iopamidol', 'type': 'DRUG', 'otherNames': ['Isovue', 'Niopam', 'Solutrast'], 'description': 'Given via epidural', 'armGroupLabels': ['Group E (TEA)']}, {'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'otherNames': ['Bupivacaine Liposome Injectable Suspension', 'Exparel'], 'description': 'Given injection', 'armGroupLabels': ['Group RS (rectus sheath block)']}, {'name': 'Medical Chart Review', 'type': 'OTHER', 'otherNames': ['Chart Review'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group E (TEA)', 'Group RS (rectus sheath block)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group E (TEA)', 'Group RS (rectus sheath block)']}, {'name': 'Thoracic Epidural Analgesia', 'type': 'DRUG', 'otherNames': ['TEA', 'Thoracic Epidural'], 'description': 'Undergo thoracic epidural placement', 'armGroupLabels': ['Group E (TEA)']}, {'name': 'Ultrasound Imaging', 'type': 'PROCEDURE', 'otherNames': ['2-Dimensional Grayscale Ultrasound Imaging', '2-Dimensional Ultrasound Imaging', '2D-US', 'Ultrasonography', 'Ultrasound', 'Ultrasound Test', 'Ultrasound, Medical', 'US'], 'description': 'Undergo ultrasound', 'armGroupLabels': ['Group RS (rectus sheath block)']}, {'name': 'X-Ray Imaging', 'type': 'PROCEDURE', 'otherNames': ['Conventional X-Ray', 'Diagnostic Radiology', 'Medical Imaging, X-Ray', 'Plain film radiographs', 'Radiographic Imaging', 'Radiographic imaging procedure (procedure)', 'Radiography', 'RG', 'Static X-Ray', 'X-Ray'], 'description': 'Undergo x-ray', 'armGroupLabels': ['Group E (TEA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flaherty', 'role': 'CONTACT', 'email': 'jflahert@umn.edu', 'phone': '314-322-3474'}, {'name': 'James Flaherty', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'James Flaherty', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota Masonic Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}