Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-30 @ 8:41 AM
Study NCT ID:
NCT01317368
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical 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': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.', 'timeFrame': '4 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)', 'timeFrame': 'Recorded 0-24 hours postoperative', 'description': 'This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative, while the patient is supine in his bed.\n\nThis outcome is recorded in and compared between all three groups.'}, {'measure': 'VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)', 'timeFrame': 'Recorded 0-24 hours postoperative', 'description': 'This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative. This outcome is recorded in and compared between all three groups.'}, {'measure': 'Nausea', 'timeFrame': 'Recorded 0-24 hours postoperative', 'description': 'On a scale ranging none-mild-moderate-severe at 1, 2, 4, 6, 8, 20, 24 hours postoperative.\n\nThis outcome is recorded in and compared between all three groups'}, {'measure': 'Sedation', 'timeFrame': 'Recorded at 0-24 hours postoperative', 'description': 'On a scale ranging none-mild-moderate-severe this outcome is assessed at 1, 2, 4, 6, 8, 20 and 24 hours postoperative.\n\nThis outcome is recorded in and compared between all three groups.'}, {'measure': 'Vomiting', 'timeFrame': 'Recorded 0-24 hours postoperative', 'description': 'The number of times the patient produces more than 10 mL of vomit. Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded in and compared between all three groups'}, {'measure': 'On-going morphine consumption', 'timeFrame': 'Recorded 0-24 postoperative', 'description': 'Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded and compared between all three groups'}, {'measure': 'Cumulated morphine consumption', 'timeFrame': '24 hours postoperative', 'description': 'This outcome is recorded in and compared between all three groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative analgesic treatment', 'TAP block', 'Prostatectomy', 'Double blinded randomized clinical trial'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed.\n\nThe different treatments the investigators wish to investigate is:\n\n1. Transversus Abdominis Plane (TAP) block.\n\n The TAP block is a rather new method, where a local anaesthetic is deposited between the two inner abdominal muscles. Between these muscles, the nerves that innervates the anterior part of the abdominal wall is situated.\n2. Wound infiltration\n\n In this method you deposit a local anaesthetic in the edges of the wound.\n3. Placebo\n\nNo active local treatment is given.\n\nAll patients who wish to participate will be allocated to one of three different treatment groups.\n\nGroup 1:\n\nWill receive TAP block with a local anaesthetic and wound infiltration with saline.\n\nGroup 2:\n\nWill receive wound infiltration with a local anaesthetic and TAP block with saline.\n\nGroup 3:\n\nWill receive TAP block with saline and wound infiltration with saline.\n\nBeside this local treatment all patients will be given systemic Paracetamol (tablet) and Ibuprofen (tablet).\n\nIn addition all patients will be given a pump containing morphine. The pump is connected to a button which the patient can activate when they experience pain. This enables the patient to control how much morphine he needs, following the operation.\n\nThe hypothesis is that the TAP block is superior in reducing pain and thereby reducing morphine consumption compared to wound infiltration and placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 18 and \\< 35\n* Patients who have given their informed consent and have fully understood the nature and limitations of the study\n* Patient who is planned for radical prostatectomy\n\nExclusion Criteria:\n\n* Not able to cooperate to complete the study\n* Is not able to speak and understand danish\n* Allergy towards the drugs which is used in the study\n* Daily use of strong opioids\n* Infection at the injection area'}, 'identificationModule': {'nctId': 'NCT01317368', 'briefTitle': 'The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SM1-AS-2010'}, 'secondaryIdInfos': [{'id': '2010-024153-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block', 'description': 'TAP block with Ropivacaine\n\nWound infiltration with Saline', 'interventionNames': ['Drug: Naropine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wound infiltration', 'description': 'TAP block with Saline.\n\nWound infiltration with Ropivacaine.', 'interventionNames': ['Drug: Naropine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'TAP block with Saline.\n\nWound infiltration with Saline.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Naropine', 'type': 'DRUG', 'otherNames': ['Ropivacaine', 'TAP block', 'Wound infiltration', 'Placebo'], 'description': '20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP.\n\nAt the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration.\n\nBoth procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.', 'armGroupLabels': ['TAP block']}, {'name': 'Naropine', 'type': 'DRUG', 'otherNames': ['Ropivacaine', 'TAP block', 'Wound infiltration', 'Placebo'], 'description': '20 mL Saline 0,9% is deposited on each side (40 mL in total) in the TAP.\n\nAt the same time 40 mL Ropivacaine 0,75% will be deposited subcutaneously as wound infiltration.\n\nBoth procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.', 'armGroupLabels': ['Wound infiltration']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Ropivacaine', 'TAP block', 'Wound infiltration'], 'description': '20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP.\n\nAt the same time 40 mL Saline 0,9% will be given as wound infiltration.\n\nBoth procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet'}], 'overallOfficials': [{'name': 'Birgitte Ruhnau, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology, Abdominal Centre, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Birgitte Ruhnau', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}