Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
Study NCT ID:
NCT03013361
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2017-01-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery', 'timeFrame': '30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.'}], 'secondaryOutcomes': [{'measure': 'Time to first administration of rescue analgesia was recorded.', 'timeFrame': '8 hours'}, {'measure': 'Patient satisfaction score', 'timeFrame': '8 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ropivacaine, bupivacaine'], 'conditions': ['Functional Endoscopic Sinus Surgery (FESS)']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the current evidences regarding the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia in this study.', 'detailedDescription': "Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the treatment of sinonasal disease. Although it is a minimally invasive and less traumatic procedure, it is usually associated with pain of mild to moderate intensity which reaches its maximum level in the first few postoperative hours. However, even low-level postoperative pain may be associated with delayed functional recovery and it frequently contributes to dissatisfaction with the procedure delay in return to work and readmission after surgery. Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide perioperative analgesia after FESS. Integration of regional anaesthesia with general anaesthesia technique can provide a better hemodynamic control, less perioperative opioid use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use may be translated into a less postoperative nausea \\& vomiting, rapid recovery and early hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 American Society of Anesthesiologists (ASA) physical status I and II patients\n* aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were enrolled\n\nExclusion Criteria:\n\n* Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or coagulopathy\n* History of allergy to any of the medications being used in the study\n* Previous surgery for sinonasal disease\n* Pre-existing chronic pain not related to chronic rhinosinusitis\n* Taking prescription pain medications or antidepressants\n* Chronic alcohol or drug abuse\n* Inability to comprehend the study protocol\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03013361', 'briefTitle': 'Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '9157/PG2Trg/2012/15727'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (n=20)', 'description': 'Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group R (n=20):', 'description': 'Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine.', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group S (n=20, Control):', 'description': 'Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline.', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Anawin'], 'description': 'Post operative pain control', 'armGroupLabels': ['Group B (n=20)']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Ropin'], 'description': 'Post operative pain control', 'armGroupLabels': ['Group R (n=20):']}, {'name': 'Normal Saline', 'type': 'OTHER', 'otherNames': ['Saline'], 'description': 'Acts as comparator', 'armGroupLabels': ['Group S (n=20, Control):']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sameer Sethi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGIMER, Chandigarh,India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Sameer Sethi', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}