Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT02725359
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C023754', 'term': 'tizanidine'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-03-28', 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog pain score', 'timeFrame': 'postoperative first hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative second hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 4th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 8th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 12th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 24th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'First 24 hours total opioid consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thyroidectomy pain', 'Tizanidine', 'Postoperative analgesia', 'Ultrasound guided Superficial cervical plexus block'], 'conditions': ['Thyroidectomy']}, 'referencesModule': {'references': [{'pmid': '26555871', 'type': 'BACKGROUND', 'citation': 'Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.'}, {'pmid': '26962521', 'type': 'BACKGROUND', 'citation': 'Talakoub R, Abbasi S, Maghami E, Zavareh SM. The effect of oral tizanidine on postoperative pain relief after elective laparoscopic cholecystectomy. Adv Biomed Res. 2016 Feb 8;5:19. doi: 10.4103/2277-9175.175905. eCollection 2016.'}, {'pmid': '25344881', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Tas Z, Toker K, Solak M. Ultrasound guided bilateral cervical plexus block reduces postoperative opioid consumption following thyroid surgery. J Clin Monit Comput. 2015 Oct;29(5):579-84. doi: 10.1007/s10877-014-9635-x. Epub 2014 Oct 26.'}, {'pmid': '29468508', 'type': 'DERIVED', 'citation': 'Ahiskalioglu A, Yayik AM, Oral Ahiskalioglu E, Dostbil A, Doymus O, Karadeniz E, Ari MA, Sengoz F, Alici HA, Celik EC. Ultrasound-guided bilateral superficial cervical block and preemptive single-dose oral tizanidine for post-thyroidectomy pain: a randomized-controlled double-blind study. J Anesth. 2018 Apr;32(2):219-226. doi: 10.1007/s00540-018-2468-x. Epub 2018 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients.\n\na2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions.\n\nUltrasound (US) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. Analgesic effect of US guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has not been reported yet.\n\nThe aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores, analgesic consumption, analgesic related side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologist's physiologic state I-III patients undergoing thyroidectomy\n\nExclusion Criteria:\n\n* chronic pain\n* bleeding disorders\n* renal or hepatic insufficiency\n* patients on chronic non-steroidal anti-inflammatory medications\n* recurrent goiter\n* emergency cases"}, 'identificationModule': {'nctId': 'NCT02725359', 'acronym': 'PTUSGSCB', 'briefTitle': 'Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy', 'orgStudyIdInfo': {'id': 'AUTF ANESTHESIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side', 'interventionNames': ['Drug: Placebo', 'Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Tizanidine', 'description': 'Group Tizanidine (Group T) will receive 6 mg tizanidine 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side', 'interventionNames': ['Drug: Tizanidine', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side', 'interventionNames': ['Drug: Placebo', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo pill'], 'description': 'Group Placebo: will receive a placebo pill 1 hour before surgery', 'armGroupLabels': ['Bupivacaine', 'Placebo']}, {'name': 'Tizanidine', 'type': 'DRUG', 'otherNames': ['Sirdalud MR'], 'description': 'Group T: 6 mg tizanidine1 hour before surgery', 'armGroupLabels': ['Tizanidine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side', 'armGroupLabels': ['Bupivacaine', 'Tizanidine']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Saline block'], 'description': 'USG guided SCPB with saline bilaterally 10 ml each side', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Yakutiye', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.89821, 'lon': 41.26916}}], 'overallOfficials': [{'name': 'Ali Ahiskalioglu, Ass.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University Anesthesiology and Reanimation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ali Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}