Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-03 @ 5:09 PM
Study NCT ID:
NCT05214261
Status:
RECRUITING
Last Update Posted:
2022-01-28
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic-guided TAP Block vs Epidural Analgesia
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': 'D012449', 'term': 'Safety'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of post-operative hospital stay after elective laparoscopic colorectal surgery.', 'timeFrame': 'Up to 1 month', 'description': 'The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery'}], 'secondaryOutcomes': [{'measure': 'Overall operating theatre time', 'timeFrame': 'Up to 10 hours', 'description': 'Overall operating theatre time'}, {'measure': 'Post-operative morphine milligram equivalents recruitments', 'timeFrame': 'Up to 1 month', 'description': 'Post-operative morphine recruiments'}, {'measure': 'Visual analogue scale', 'timeFrame': 'Up to 1 month', 'description': 'The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.'}, {'measure': 'Overall benefit of analgesia score (OBAS)', 'timeFrame': 'Up to 1 month', 'description': 'The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia'}, {'measure': 'Hospital readmission', 'timeFrame': '30 and 90-day', 'description': 'Post-operative readmissions'}, {'measure': 'Time to first flatus', 'timeFrame': 'Up to 1 month', 'description': 'Post-operative flatus'}, {'measure': 'Time to first bowel movement', 'timeFrame': 'Up to 1 month', 'description': 'Post-operative bowel movement'}, {'measure': 'Time to post-operative mobilization', 'timeFrame': 'Up to 1 month', 'description': 'Post-operative mobilization'}, {'measure': 'Overall cost-effectiveness', 'timeFrame': 'Up to 6 months', 'description': 'Overall cost-effectiveness'}, {'measure': 'Post-operative complications related to interventions according to Clavien-Dindo classification', 'timeFrame': '30 and 90-day', 'description': 'Post-operative complications'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.', 'detailedDescription': 'In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'IInclusion criteria\n\n* Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area\n* Patients able to provide informed written consent\n* Patients capable of completing questionnaires at the time of consent\n\nExclusion criteria\n\n* Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone\n* Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)\n* Urgent or emergent surgery precluding epidural catheter placement or TAP block\n* Systemic Infection contraindicating epidural catheter placement or TAP block\n* Rectal surgery\n* Pregnant or suspected pregnancy\n* Age \\< 18 years\n* Planned open surgery\n* Planned bowel stoma (protective diversion and/or permanent stoma)\n* Unwillingness to participate in follow-up assessments\n* Patients with severe chronic pain\n* Known sensibility for opioid side effects\n* i.v.-PCA is contraindicated (for example drug abuse)\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT05214261', 'briefTitle': 'Laparoscopic-guided TAP Block vs Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Oulu University Hospital'}, 'officialTitle': 'Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '112/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP block group', 'description': 'Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery', 'interventionNames': ['Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural analgesia group', 'description': 'Patients undergo epidural catheters placement for laparoscopic colorectal surgery', 'interventionNames': ['Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia']}], 'interventions': [{'name': 'Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia', 'type': 'OTHER', 'description': 'Patients in the TAP group will be given a laparoscopic-assisted TAP block with a total of 2mg/kg of 0.25% bupivacaine in the bilateral subcostal region into four spots of the bilateral subcostal region, two on both sides of the lateral abdomen between the anterior iliac spine and lower costal arch. The TAP block is performed after the first trocar placement before the insertion of other trocars and the beginning of the surgical intervention.\n\nIn the control group epidural catheters will be placed using landmark- and loss-of-resistance techniques while the patient is on the operating table. Infusions of 4ml/h containing 0.125% levobupivacaine and 5.5 μg/mL fentanyl will be started with a CADD Solis VIP-infusion pump at the time of anesthesia induction.', 'armGroupLabels': ['Epidural analgesia group', 'TAP block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Heikki Huhta, PhD', 'role': 'CONTACT', 'email': 'heikki.huhta@ppshp.fi', 'phone': '+3583152011'}, {'name': 'Jukka Rintala, PhD', 'role': 'CONTACT', 'email': 'jukka.rintala@ppshp.fi', 'phone': '+3583152011'}, {'name': 'Mari Pohjola, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nina Rotko, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Janne H Liisanantti, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tero Rautio, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Surgery and Intensive Care Research Unit', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'centralContacts': [{'name': 'Heikki Huhta, PhD', 'role': 'CONTACT', 'email': 'heikki.huhta@ppshp.fi', 'phone': '+3583152011'}, {'name': 'Jukka Rintala, PhD', 'role': 'CONTACT', 'email': 'jukka.rintala@ppshp.fi', 'phone': '+3583152011'}], 'overallOfficials': [{'name': 'Heikki Huhta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oulu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastointestinal Surgeon, Adjunct Professor', 'investigatorFullName': 'Heikki Huhta', 'investigatorAffiliation': 'Oulu University Hospital'}}}}