Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-03-04 @ 10:22 AM
Study NCT ID:
NCT02539693
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2015-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare analgesic consumption using questionnaire', 'timeFrame': 'Patients will be followed-up after the operation, an expected average of five days'}], 'secondaryOutcomes': [{'measure': 'Time needed to return to normal activity noted by calling the patients', 'timeFrame': 'Patients will be followed-up after the operation, an expected average of five days'}, {'measure': 'Pain using verbal numeric rating scale (VNRS)', 'timeFrame': 'Patients will be followed-up after the operation, an expected average of five days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption.\n\nGiven the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.', 'detailedDescription': 'Study design and sampling\n\nThis is a prospective study with a randomized double-blind design that will be conducted between October 2015 and October 2016.\n\nPatients scheduled for pilonidal sinus surgery will be included. Patients will be randomly distributed to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine, while group two will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.\n\nAnesthetic techniques\n\nBeing a double-blinded study, a specialized nurse will prepare the syringes for each patient.\n\nSacrococcygeal local anesthesia technique\n\nThe Sacrococcygeal block will be performed with the patient in the prone position. Four injection sites are marked on the skin after aseptic preparation.\n\nThe sites are placed as follows: 4 cm below and above the pilonidal sinus and 3 cm lateral to its center on both sides. Therefore a "lozenge" is formed by connecting the 4 sites.\n\nAt first, an injection of 0.3 ml lidocaine 1% is injected at each site using an 8-mm 30G needle. Then 4 injections are admitted to each of the 4 injection sites in turn, with equal supply of the anesthetic mixture in the following manner: a 10-mm 27G needle containing the anesthetic mixture is introduced perpendicularly to the skin and the mixture is infiltrated. The needle is partially withdrawn and reinserted at 45 degrees to the skin aiming towards the center of the pilonidal sinus and an injection will be performed. Then the needle is partially withdrawn again and reinserted at an angle of 45 degrees to the skin aiming at one side of the lozenge then at the other side where injections are done.\n\nIn case of a multiple pilonidal orifices, a hexagon is done. These sites are then anesthetized as previously described.\n\nAnesthetic mixture\n\nFor group 1, the syringe will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).\n\nAs for group 2, the syringes will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).\n\nDepending on each patient\'s weight and type of pilonidal sinus, the anesthetic mixture might vary from 30 to 40 mL in total.\n\nData collection\n\nDemographic data, type and duration of surgery will be recorded. Haemodynamics will be registered at all times (pre-operatively, intra-operatively and post-operatively).\n\nPain will be assessed using VNRS with 0 being no pain and 10 maximum pain for 48 hours post-operatively.\n\nAs for postoperative analgesia consumption, patients with a VNRS score less than 3 are given paracetamol 1000 mg each 8 hours. If VNRS is between three and four, patients are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours and if the VNRS score is greater or equal to five, patients receive 1 mg/kg Dolosal.\n\nReturn to normal activity will be defined by the ability to sit, walk and work comfortably and will be assessed by calling the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for pilonidal sinus surgery\n\nExclusion Criteria:\n\n* Patients who have allergic reactions to lidocaine'}, 'identificationModule': {'nctId': 'NCT02539693', 'briefTitle': 'Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Makassed General Hospital'}, 'officialTitle': 'Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '082015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine 75', 'description': 'Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).', 'interventionNames': ['Drug: Clonidine 75 µg/mL in sacrococcygeal block', 'Drug: Lidocaine', 'Procedure: Pilonidal sinus']}, {'type': 'EXPERIMENTAL', 'label': 'Clonidine 150', 'description': 'Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).', 'interventionNames': ['Drug: Clonidine 150 µg/mL in sacrococcygeal block', 'Drug: Lidocaine', 'Procedure: Pilonidal sinus']}], 'interventions': [{'name': 'Clonidine 75 µg/mL in sacrococcygeal block', 'type': 'DRUG', 'description': 'Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture', 'armGroupLabels': ['Clonidine 75']}, {'name': 'Clonidine 150 µg/mL in sacrococcygeal block', 'type': 'DRUG', 'description': 'Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture', 'armGroupLabels': ['Clonidine 150']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': '3 ml lidocaine 1% is injected at each block site', 'armGroupLabels': ['Clonidine 150', 'Clonidine 75']}, {'name': 'Pilonidal sinus', 'type': 'PROCEDURE', 'description': 'Removal of pilonidal sinus', 'armGroupLabels': ['Clonidine 150', 'Clonidine 75']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Zoher Naja, MD', 'role': 'CONTACT', 'email': 'zouhnaja@yahoo.com', 'phone': '+9611636000', 'phoneExt': '6405'}], 'facility': 'Makassed General Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Zoher Naja, MD', 'role': 'CONTACT', 'email': 'zouhnaja@yahoo.com', 'phone': '+9611636000', 'phoneExt': '6405'}], 'overallOfficials': [{'name': 'Zoher Naja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makassed General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makassed General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairperson of Anesthesia and Pain Management Department', 'investigatorFullName': 'Zoher Naja', 'investigatorAffiliation': 'Makassed General Hospital'}}}}