Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-01 @ 9:16 AM
Study NCT ID:
NCT06860893
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2025-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy
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': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded placebo controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to discharge from the post anesthesia care unit.', 'timeFrame': '24 hrs', 'description': 'Minutes of stay in the post anesthesia care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal anesthesia', 'Robotic assisted prostatectomy', 'Postoperative pain'], 'conditions': ['Prostate Cancer Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesised that spinal anesthesia as an adjunct to general anesthesia would facilitate faster recovery and less pain in patients undergoing laparoscopic robotic prostatectomy. A double-blind placebo-controlled study was subsequently designed.', 'detailedDescription': 'Patients were allocated to either intrathecal injection of bupivacaine/morphine or a sham spinal procedure. All patients were placed in a sitting position and the skin over the lumbar region of the back was disinfected with chlorhexidine and draped sterile. In the intervention group the skin was infiltrated with 5 mL of lidocaine 10 mg/mL and a sterile 27-gauge pencil-point needle (Pajunk, GA, USA) was subsequently entered into the intrathecal space at the L2-3 or L3-4 interspace. After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally. Patients in the placebo group received an identical treatment as the patients in the intervention group, except for the intrathecal injection. After the skin was infiltrated with 5 mL of lidocaine 10 mg/mL, the attending anesthesiologist pressed one finger at the skin and talked as if she was giving an intrathecal injection at the L3-4 interspace. All patients were treated by the same anesthesiologist (MA).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Prostate cancer\n\nExclusion Criteria:\n\n* Benign prostate disease'}, 'identificationModule': {'nctId': 'NCT06860893', 'briefTitle': 'Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Spinal Anesthesia as an Adjunct to General Anesthesia for Robotic Assisted Laparoscopic Prostatectomy - a Randomised Placebo- Controlled Trial', 'orgStudyIdInfo': {'id': 'Prostate REK 866656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal anesthesia', 'description': 'After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally.', 'interventionNames': ['Drug: Spinal Anesthesia with Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Local skin infiltration with lidocain 10 mg/ml', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Spinal Anesthesia with Bupivacaine', 'type': 'DRUG', 'description': 'After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally.', 'armGroupLabels': ['Spinal anesthesia']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Local skin infiltration with lidocaine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}