Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-29 @ 7:24 AM
Study NCT ID:
NCT02065804
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2014-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2014-02-15', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normalized summed pain intensity differences (SPID)', 'timeFrame': '20 min', 'description': 'The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.'}], 'secondaryOutcomes': [{'measure': 'Thermal thresholds', 'timeFrame': '20 min', 'description': 'Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo'}, {'measure': 'Suprathreshold heat stimulation', 'timeFrame': '20 min', 'description': 'Quantitative changes in pain rating to suprathreshold heat stimulation after bupivacaine compared to placebo'}, {'measure': 'Pressure pain thresholds', 'timeFrame': '20 min', 'description': 'Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo'}, {'measure': 'Sensory mapping', 'timeFrame': '20 min', 'description': 'Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo'}, {'measure': 'Pain questionnaire', 'timeFrame': '7 days', 'description': 'Quantitative changes in summed pain intensity differences (SPIDs) assessed morning and evening after bupivacaine compared to placebo'}, {'measure': 'Sleep quality questionnaire', 'timeFrame': '7 days', 'description': 'Quantitative changes in sleep quality assessed each morning after bupivacaine compared to placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Herniorrhaphy', 'Surgical Equipment', 'Chronic Pain', 'Inguinal Herniorrhaphy', 'Laparoscopy', 'Surgical Outcome'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '21479588', 'type': 'BACKGROUND', 'citation': 'Linderoth G, Kehlet H, Aasvang EK, Werner MU. Neurophysiological characterization of persistent pain after laparoscopic inguinal hernia repair. Hernia. 2011 Oct;15(5):521-9. doi: 10.1007/s10029-011-0815-z. Epub 2011 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.\n\nThis study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.\n\nThe hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following laparoscopical groin hernia repair.', 'detailedDescription': 'This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with persistent pain (\\< 6 mo) after laparoscopical groin hernia repair\n* Patients with maximal pain area 3 cm or less from the superficial inguinal ring\n* Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)\n\nExclusion Criteria:\n\n* Known allergy to bupivacaine or other local anesthetics of amide-type\n* Declared incapable of making his/hers own affairs\n* Does not comprehend Danish in writing or speech\n* Cognitive impairment to a degree influencing the testing reliability\n* Known recurrence of the inguinal hernia\n* Other surgical procedures performed in the groin or on the external genitals\n* Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc\n* Abuse of alcohol or drugs\n* Unable to cooperate with the sensory examinations'}, 'identificationModule': {'nctId': 'NCT02065804', 'acronym': 'Trigger-lap', 'briefTitle': 'Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Trigger-point Blockade in Persistent Pain After Laparoscopically Assisted Groin Hernia Repair', 'orgStudyIdInfo': {'id': 'H-3-2011-130-lap'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active drug', 'description': '10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Bupivacain "SAD"', '0.9% Sodium-chloride'], 'description': 'injection, once, 5 min', 'armGroupLabels': ['Active drug', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Mads Werner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK'}, {'name': 'Henrik Kehlet, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be submitted as supplementary material in the final manuscript'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DMSc', 'investigatorFullName': 'mads u werner', 'investigatorAffiliation': 'University of Copenhagen'}}}}