Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05504551
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2022-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study group receives superficial cervical plexus block with lidocaine and bupivacaine control group receives superficial cervical plexus block using normal saline as a placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PONV incidence over 24hour postoperative', 'timeFrame': '24 hours', 'description': 'incidence of PONV according to PONV score from 0 to 3 where: 0= No nausea,no vomiting, 1= Nausea present, no vomiting, 2= Nausea present, vomiting present, 3= Vomiting\\>2 episodes in 30 minutes, i.e., number of patients with PONV score of 0, number of patients with PONV score of 1, number of patients with PONV score of 2 and number of patients with PONV score of 3.'}], 'secondaryOutcomes': [{'measure': 'post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.', 'timeFrame': 'up to 24 hours postoperative', 'description': 'post operative pain is assessed by visual analogue score from 0 to 10. patients are educated that 0= no pain, 5= distressing pain, 10= unbearable pain.'}, {'measure': 'Intraoperative and postoperative complications', 'timeFrame': '24 hours', 'description': 'Complications in the form of bleeding and facial nerve palsy'}, {'measure': 'To monitor intraoperative hemodynamics', 'timeFrame': 'up to 4 hours', 'description': 'To monitor intraoperative heart rate and blood pressure'}, {'measure': 'Side effects and toxicity of drugs', 'timeFrame': '24 hours', 'description': 'record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.'}, {'measure': 'Need for postoperative analgesia', 'timeFrame': '24 hours', 'description': 'first analgesic request'}, {'measure': 'To detect complications of regional ear block', 'timeFrame': '24 hours', 'description': 'record complications include (hematoma-facial nerve palsy-oedema)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nause, vomiting, tympanomastoid operations'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '23035051', 'type': 'BACKGROUND', 'citation': 'Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.'}, {'pmid': '20850082', 'type': 'BACKGROUND', 'citation': 'Liang S, Irwin MG. Review of anesthesia for middle ear surgery. Anesthesiol Clin. 2010 Sep;28(3):519-28. doi: 10.1016/j.anclin.2010.07.009. Epub 2010 Aug 7.'}, {'pmid': '22971490', 'type': 'BACKGROUND', 'citation': 'Cai HD, Lin CZ, Yu CX, Lin XZ. Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J Int Med Res. 2012;40(4):1390-8. doi: 10.1177/147323001204000417.'}]}, 'descriptionModule': {'briefSummary': 'post operative nausea and vomiting are very common after tympanomastoid operations, in this study we are investigating the effect of superficial cervical plexus block on the incidence and severity of those post operative complications.', 'detailedDescription': 'various treatments and regimens have been tried to overcome the problem of postoperative nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so promising in this regards as it may reduce the incidence and severity of PONV through 3 mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally through decreasing intra and post operative opioid consumption due to adequate analgesia which in turn avoids opioids side effects including PONV.\n\nthe study group will receive superficial cervical plexus block while the control will receive the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and severity of PONV will be recoded according to a scale to find the difference between both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients belonging to American Society of Anesthesiologists physical status I-II.\n* operation time less than 4 hours.\n\nExclusion Criteria:\n\n* • American Society of Anesthesiology (ASA) physical status ≥ III.\n\n * Uncooperative or mentally retarded patients.\n * Known Allergy or hypersensitivity to lidocaine or bupivacaine.\n * Patients known to have gastritis or Gastro-oesophageal reflux disease (GERD).\n * History of PONV or motion sickness.\n * Operation duration (short less than 30 minutes or prolonged more than 240 min).\n * Patients with chronic renal disease (serum creatinine level ≥2.0mg/dl) or on renal replacement therapy (dialysis).\n * Patients with chronic cholecystitis (history of recurrent or persistent vomiting)\n * Skin inflammation and cellulitis.'}, 'identificationModule': {'nctId': 'NCT05504551', 'briefTitle': 'Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Superficial Cervical Plexus Block on Incidence and Severity of Post Operative Nausea and Vomiting in Tympanomastoid Operations in Adults, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'N-90-2019/MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Superficial cervical plexus block (SCP) block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize superficial cervical plexus (SCP) posterior to the midpoint of sterno cleido mastoid (SCM) muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.', 'interventionNames': ['Procedure: ultrasound guided superficial cervical plexus block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group S', 'description': 'SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, 10 ml of normal saline is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.', 'interventionNames': ['Procedure: ultrasound guided superficial cervical plexus block']}], 'interventions': [{'name': 'ultrasound guided superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) are injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel needle Echogenic Needle.', 'armGroupLabels': ['group B', 'group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12521', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty Of Medicine- Cairo Univesity', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sahar Elshall, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and intensive care medicine- Faculty of Medicine', 'investigatorFullName': 'Wael El-Siory', 'investigatorAffiliation': 'Cairo University'}}}}