Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT06531603
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-15', 'size': 59361, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-12T02:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both patients and assessor were unaware of interventions'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of analgesia', 'timeFrame': 'Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure', 'description': 'Time from procedure to requirement of rescue analgesia'}], 'secondaryOutcomes': [{'measure': 'Opioid sparing', 'timeFrame': 'Total dose of nalbuhine consumption in 1st 24 hrs after procedure', 'description': 'Total amount of opioid consumtion in the first 24 post procedure.'}, {'measure': 'Blood pressure', 'timeFrame': 'Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively', 'description': 'Mean pressue will be measured'}, {'measure': 'Hear rate', 'timeFrame': 'Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs', 'description': 'Heart rate will be measured'}, {'measure': 'Neausea', 'timeFrame': 'Every 30 minutes for 4 hrs then 2hrly for 24 hrs', 'description': 'Felling of nasueas'}, {'measure': 'Vomiting', 'timeFrame': 'Every 3 minutes for first 4 hrs then 2hrly for 24 hrs', 'description': 'Urge to vomit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Dexmedetomidine', 'Post operative analgesia', 'Abdominal surgery'], 'conditions': ['Post Operative Pain', 'Bradycardia', 'Hypotension', 'Nausea', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '24438599', 'type': 'RESULT', 'citation': 'Chen J, Zhou JQ, Chen ZF, Huang Y, Jiang H. Efficacy and safety of dexmedetomidine versus propofol for the sedation of tube-retention after oral maxillofacial surgery. J Oral Maxillofac Surg. 2014 Feb;72(2):285.e1-7. doi: 10.1016/j.joms.2013.10.006. Epub 2013 Oct 25.'}, {'pmid': '23041302', 'type': 'RESULT', 'citation': 'Champaneria R, Shah L, Geoghegan J, Gupta JK, Daniels JP. Analgesic effectiveness of transversus abdominis plane blocks after hysterectomy: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2013 Jan;166(1):1-9. doi: 10.1016/j.ejogrb.2012.09.012. Epub 2012 Oct 4.'}, {'pmid': '21851346', 'type': 'RESULT', 'citation': 'Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.'}, {'pmid': '27307177', 'type': 'RESULT', 'citation': 'Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15.'}, {'pmid': '22546966', 'type': 'RESULT', 'citation': 'Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.'}, {'pmid': '24882606', 'type': 'RESULT', 'citation': 'Bhatia N, Arora S, Jyotsna W, Kaur G. Comparison of posterior and subcostal approaches to ultrasound-guided transverse abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy. J Clin Anesth. 2014 Jun;26(4):294-9. doi: 10.1016/j.jclinane.2013.11.023. Epub 2014 Jun 2.'}, {'pmid': '16436839', 'type': 'RESULT', 'citation': 'Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.'}, {'pmid': '27082959', 'type': 'RESULT', 'citation': 'Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016.'}, {'pmid': '15680647', 'type': 'RESULT', 'citation': 'Ard JL Jr, Bekker AY, Doyle WK. Dexmedetomidine in awake craniotomy: a technical note. Surg Neurol. 2005 Feb;63(2):114-6; discussion 116-7. doi: 10.1016/j.surneu.2004.02.029.'}, {'pmid': '12145072', 'type': 'RESULT', 'citation': 'Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.'}, {'pmid': '28058142', 'type': 'RESULT', 'citation': 'Altuntas G, Akkaya OT, Ozkan D, Sayin MM, Balas S, Ozlu E. Comparison of Intraabdominal and Trocar Site Local Anaesthetic Infiltration on Postoperative Analgesia After Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):306-311. doi: 10.5152/TJAR.2016.75983. Epub 2016 Dec 1.'}, {'pmid': '22286518', 'type': 'RESULT', 'citation': 'Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.'}, {'pmid': '23811424', 'type': 'RESULT', 'citation': 'Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.'}]}, 'descriptionModule': {'briefSummary': "Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.", 'detailedDescription': 'This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age limit: 18-60 years\n2. Gender of patient i.e., male or female\n3. Patients listed for abdominal surgeries\n4. American Society of Anesthesiologists (ASA) status of I or II\n\nExclusion Criteria:\n\n1. Patients with history of drug allergy\n2. Patients who undergone any analgesia in past 24 hr\n3. Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment\n4. American Society of Anesthesiologists (ASA) status III or IV\n5. Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation."}, 'identificationModule': {'nctId': 'NCT06531603', 'briefTitle': 'Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sahiwal medical college sahiwal'}, 'officialTitle': 'Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia', 'orgStudyIdInfo': {'id': 'IRB29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine group', 'description': 'Patients receiving Bupivacaine plus placebo for wound infiltration after abdominal surgery for pain control.', 'interventionNames': ['Drug: bupivacaine wound infilteration']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine plus Dexmedetomidine group', 'description': 'Patients receiving Bupivacaine plus Dexmedetomidine for wound infiltration after abdominal surgery for pain control.', 'interventionNames': ['Drug: Bupivacaine plus dexmedetomidine wound infilteration']}], 'interventions': [{'name': 'bupivacaine wound infilteration', 'type': 'DRUG', 'otherNames': ['LA infiltration'], 'description': 'drug was given at the end of surgery', 'armGroupLabels': ['Bupivacaine group']}, {'name': 'Bupivacaine plus dexmedetomidine wound infilteration', 'type': 'DRUG', 'otherNames': ['LA + Dex infiltration'], 'description': 'drug was given at the end of surgery', 'armGroupLabels': ['Bupivacaine plus Dexmedetomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57000', 'city': 'Sahiwal', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sahiwal Medical College', 'geoPoint': {'lat': 30.66595, 'lon': 73.10186}}], 'overallOfficials': [{'name': 'M. Shahid, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahiwal medical college sahiwal'}, {'name': 'A. Riaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahiwal medical college sahiwal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not share individualized data, but the outcomes of the study will be shared in the form of manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahiwal medical college sahiwal', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muhammad Shahid', 'investigatorAffiliation': 'Sahiwal medical college sahiwal'}}}}