Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT00508092
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2007-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-22', 'studyFirstSubmitDate': '2007-07-26', 'studyFirstSubmitQcDate': '2007-07-26', 'lastUpdatePostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain score', 'timeFrame': '1 hour, 4 hours, 8 hours, 24 hours and on discharge'}], 'secondaryOutcomes': [{'measure': 'Post operative nausea and vomiting', 'timeFrame': '1 hour, 4 hours, 8 hours, 24 hours and on discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['appendicectomy', 'pain', 'local anaesthetic', 'nerve block', 'Post operative pain following appendicectomy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.', 'detailedDescription': 'Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.\n\nComparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)\n* Consent obtained\n\nExclusion Criteria:\n\n* Laparoscopic appendectomy\n* Appendectomy at time of laparotomy/other incision'}, 'identificationModule': {'nctId': 'NCT00508092', 'briefTitle': 'Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royal Berkshire NHS Foundation Trust'}, 'officialTitle': 'Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study', 'orgStudyIdInfo': {'id': '06/Q1602/168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'lanz incision appendectomy', 'interventionNames': ['Procedure: local anesthetic administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'lanz incision appendectomy', 'interventionNames': ['Procedure: local anesthetic administration']}], 'interventions': [{'name': 'local anesthetic administration', 'type': 'PROCEDURE', 'description': 'Pre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight\n\nOR\n\nPre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Jonathan K Randall, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Berkshire NHS Foundation Trust'}, {'name': 'Simon B Middleton, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Berkshire NHS Foundation Trust'}, {'name': 'Arnold Goede, MRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal Berkshire NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Berkshire NHS Foundation Trust', 'class': 'OTHER_GOV'}}}}