Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT01452633
Status:
UNKNOWN
Last Update Posted:
2013-06-10
First Post:
2011-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in post-operative pain at large lateral port sites', 'timeFrame': '4 and 24 hours after surgery', 'description': 'visual analog scoring of post-operative pain in a control and a treatment group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'laparoscopy', 'reduction'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.', 'detailedDescription': 'The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing laparoscopic surgery\n\nExclusion Criteria:\n\n* Cardiovascular instability\n* malignancies\n* pulmonary conditions incompatible with laparoscopic surgery'}, 'identificationModule': {'nctId': 'NCT01452633', 'briefTitle': 'Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites', 'orgStudyIdInfo': {'id': '241577-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Preincision Placebo', 'description': 'This group of patients will receive saline injection at study port site before incision', 'interventionNames': ['Drug: Saline will be injected at the study port site prior to incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preincision Marcaine', 'description': 'This group will receive marcaine injection at the study port site prior to incision', 'interventionNames': ['Drug: 0.25% bupivicaine will be injected at the study port site prior to incision']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Postincision Placebo', 'description': 'This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure', 'interventionNames': ['Drug: 0.25% bupivicaine will be injected at the study port site prior to incision', 'Drug: Saline will be in injected into the port site prior to closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Postincision marcaine', 'description': 'This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure', 'interventionNames': ['Drug: 0.25% bupivicaine will be injected at the study port site prior to incision', 'Drug: 0.25% bupivicaine will be injected into the port site prior to closure']}], 'interventions': [{'name': '0.25% bupivicaine will be injected at the study port site prior to incision', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'Injection will precede the incision', 'armGroupLabels': ['Postincision Placebo', 'Postincision marcaine', 'Preincision Marcaine']}, {'name': 'Saline will be injected at the study port site prior to incision', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'Injection will precede incision', 'armGroupLabels': ['Preincision Placebo']}, {'name': 'Saline will be in injected into the port site prior to closure', 'type': 'DRUG', 'description': 'Saline will be injected into the port site prior to the closure without any preincisional intervention', 'armGroupLabels': ['Postincision Placebo']}, {'name': '0.25% bupivicaine will be injected into the port site prior to closure', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': '0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention', 'armGroupLabels': ['Postincision marcaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James N Droesch, MD', 'role': 'CONTACT', 'email': 'james.droesch@sbumed.org', 'phone': '631-444-2757'}, {'name': 'Todd Griffin, MD', 'role': 'CONTACT', 'email': 'todd.griffin@sbumed.org', 'phone': '6314442757'}, {'name': 'James N Droesch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'James N Droesch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Obsterics/Gynecology', 'investigatorFullName': 'James Droesch', 'investigatorAffiliation': 'Stony Brook University'}}}}