Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05984160
Status:
UNKNOWN
Last Update Posted:
2023-08-09
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization was performed by a general surgeon who would not be present during the block procedure. Patients were numbered sequentially according to the randomization scheme. Patient numbers were recorded in the follow-up files. Evaluation of the postoperative results was done by a general surgeon who was unaware of the group distributions. Since both the patients and the general surgeon who will make the evaluation did not know whether the block procedure was applied or not, the study was performed as double-blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients were divided into two groups as perigastric neural block and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'In first 24 hours', 'description': 'The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).'}, {'measure': 'Postoperative nause and vomiting', 'timeFrame': 'In first 24 hours', 'description': 'The investigators used Post operative nause and vomiting impact scale. Minimum value 0, maximum values 6. Total score \\>4 defines clinically important postoperative nause and vomiting.'}], 'secondaryOutcomes': [{'measure': 'First Rescue analgesia', 'timeFrame': 'In first 24 hours', 'description': 'Did patients need first rescue analgesia?'}, {'measure': 'Second Rescue analgesia', 'timeFrame': 'In first 24 hours', 'description': 'Did patients need second rescue analgesia?'}, {'measure': 'Rescue antiemetic', 'timeFrame': 'In first 24 hours', 'description': 'Did patients need rescue antiemetic drug?'}, {'measure': 'Time to rescue antiemetic', 'timeFrame': 'In first 24 hours', 'description': 'When patients need rescue antiemetic drug?'}, {'measure': 'Time to first rescue analgesia', 'timeFrame': 'In first 24 hours', 'description': 'When patients need first rescue analgesia?'}, {'measure': 'Time to second rescue analgesia', 'timeFrame': 'In first 24 hours', 'description': 'when patients need second rescue analgesia?'}, {'measure': 'First mobilization time', 'timeFrame': 'In first 24 hours', 'description': 'When patients start to walk?'}, {'measure': 'Operation time', 'timeFrame': 'Through operation completion, an avarage of 1 hour', 'description': 'How long did the surgery take?'}, {'measure': 'Patient satisfaction', 'timeFrame': 'In first 72 hours', 'description': 'The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).'}, {'measure': 'Pulse before block', 'timeFrame': 'at block moment', 'description': 'Pulse before block'}, {'measure': 'Pulse 10 minutes after the block', 'timeFrame': '10 minutes after the block', 'description': 'Pulse 10 minutes after the block'}, {'measure': 'Sistolic blood pressure before the block', 'timeFrame': 'at block moment', 'description': 'Sistolic blood pressure before the block'}, {'measure': 'Sistolic blood pressure 10 minutes after the block', 'timeFrame': '10 minutes after the block', 'description': 'Sistolic blood pressure 10 minutes after the block'}, {'measure': 'Diastolic blood pressure before the block', 'timeFrame': 'at block moment', 'description': 'Diastolic blood pressure before the block'}, {'measure': 'Diastolic blood pressure 10 minutes after the block', 'timeFrame': '10 minutes after the block', 'description': 'Diastolic blood pressure 10 minutes after the block'}, {'measure': 'Complication at the block site', 'timeFrame': 'Through operation, an avarage of 1 hour', 'description': 'Were there any complications during the block?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Post operative pain', 'Pain block', 'Sleeve gastrectomy'], 'conditions': ['Obesity', 'Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '12513041', 'type': 'BACKGROUND', 'citation': 'Peeters A, Barendregt JJ, Willekens F, Mackenbach JP, Al Mamun A, Bonneux L; NEDCOM, the Netherlands Epidemiology and Demography Compression of Morbidity Research Group. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003 Jan 7;138(1):24-32. doi: 10.7326/0003-4819-138-1-200301070-00008.'}, {'pmid': '25562267', 'type': 'BACKGROUND', 'citation': 'Arterburn DE, Olsen MK, Smith VA, Livingston EH, Van Scoyoc L, Yancy WS Jr, Eid G, Weidenbacher H, Maciejewski ML. Association between bariatric surgery and long-term survival. JAMA. 2015 Jan 6;313(1):62-70. doi: 10.1001/jama.2014.16968.'}, {'pmid': '35135657', 'type': 'BACKGROUND', 'citation': 'Liu JJ, Brenner DM. Opioid-Related Constipation. Gastroenterol Clin North Am. 2022 Mar;51(1):107-121. doi: 10.1016/j.gtc.2021.10.007. Epub 2022 Jan 8.'}, {'pmid': '27771314', 'type': 'BACKGROUND', 'citation': 'Budiansky AS, Margarson MP, Eipe N. Acute pain management in morbid obesity - an evidence based clinical update. Surg Obes Relat Dis. 2017 Mar;13(3):523-532. doi: 10.1016/j.soard.2016.09.013. Epub 2016 Sep 19.'}, {'pmid': '34984504', 'type': 'BACKGROUND', 'citation': "Stenberg E, Dos Reis Falcao LF, O'Kane M, Liem R, Pournaras DJ, Salminen P, Urman RD, Wadhwa A, Gustafsson UO, Thorell A. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: A 2021 Update. World J Surg. 2022 Apr;46(4):729-751. doi: 10.1007/s00268-021-06394-9. Epub 2022 Jan 4."}, {'pmid': '30706309', 'type': 'BACKGROUND', 'citation': 'Emile SH, Abdel-Razik MA, Elbahrawy K, Elshobaky A, Shalaby M, Elbaz SA, Gado WA, Elbanna HG. Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Pain and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial. Obes Surg. 2019 May;29(5):1534-1541. doi: 10.1007/s11695-019-03720-y.'}, {'pmid': '34449029', 'type': 'BACKGROUND', 'citation': 'Zengin SU, Ergun MO, Gunal O. Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Intraoperative Opioid Consumption in Bariatric Surgery. Obes Surg. 2021 Dec;31(12):5176-5182. doi: 10.1007/s11695-021-05681-7. Epub 2021 Aug 27.'}, {'pmid': '36050617', 'type': 'BACKGROUND', 'citation': 'Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.'}, {'pmid': '21997984', 'type': 'BACKGROUND', 'citation': 'Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526.'}, {'pmid': '24414338', 'type': 'BACKGROUND', 'citation': 'Rana MV, Candido KD, Raja O, Knezevic NN. Celiac plexus block in the management of chronic abdominal pain. Curr Pain Headache Rep. 2014 Feb;18(2):394. doi: 10.1007/s11916-013-0394-z.'}]}, 'descriptionModule': {'briefSummary': "Surgical treatment is the most effective way to achieve effective and sustainable weight loss in patients with obesity and to improve the comorbidities caused by it.\n\nAlthough minimally invasive bariatric surgical procedures are applied today, postoperative pain is one of the most basic problems. Opioid-derived drugs used for pain control cause respiratory depression and constipation. Enhanced Recovery After Surgery (ERAS) protocols recommend reducing opioid use after bariatric surgery to help patients have a healthier postoperative period.\n\nDifferent methods such as transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are used to reduce the postoperative opioid dose and for effective pain control. While these methods are effective in controlling somatic pain, they have no effect on visceral pain.\n\nIt has been shown that patients' pain and opioid consumption decrease especially after celiac plexus block. Vagal and sympathetic afferent stimuli from the gastrointestinal tract, on the other hand, stimulate the vomiting center and cause nausea and vomiting. Paragastric neural block is a new method performed by injecting local anesthetic into the posterosuperior paragastric area in the area covering the left gastric artery by revealing the esophagogastric junction, proximal stomach, middle of the stomach, distal antrum, hepatoduodenal ligament and stomach posterior along the border of the lesser omentum. In this way, it is aimed to prevent both visceral pain and the symptoms of nausea and vomiting.\n\nIn our study, the investigators aimed to evaluate the efficacy and safety of paragastric nerve block applied during laparoscopic sleeve gastrectomy by comparing it with the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index of over 35 and an obesity-related comorbidity,\n* Body mass index of over 40,\n* Patients who underwent laparoscopic sleeve gastrectomy,\n* ASA risk score of 2-3,\n* Agreed to be included in the study.\n\nExclusion Criteria:\n\n* Chronic pain disorder or using gabapentin,\n* Opioid addicts,\n* Using anticoagulant drugs,\n* History of previous upper gastrointestinal system surgery,\n* Surgical complications during or after surgery,\n* Hepatic or renal failure,\n* Moderate or severe cardiovascular or respiratory disease,\n* Allergy to the local anesthetic agent to be applied for the block,\n* Limited cooperation,\n* More than one surgical intervention in the same session,\n* Allergy to the drugs to be used in the postoperative treatment protocol.'}, 'identificationModule': {'nctId': 'NCT05984160', 'briefTitle': 'Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Efficacy and Safety of Paragastric Neural Block in Controlling Pain, Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy; Prospective Randomized Controlled Double-blind Study', 'orgStudyIdInfo': {'id': 'E-22686390-050.99-27043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paragastric neural block', 'description': 'Patients who were operated for sleeve gastrectomy were included in the study. Afterwards, they were divided into two groups. While pragastric neural block was applied to one group, no intervention was made to the other group.', 'interventionNames': ['Other: Paragastric neural block']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control grup'}], 'interventions': [{'name': 'Paragastric neural block', 'type': 'OTHER', 'description': "A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.", 'armGroupLabels': ['Paragastric neural block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas university', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet K Katar, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlas University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Start after the publication.', 'ipdSharing': 'YES', 'description': 'Data will be shared after the article is published.', 'accessCriteria': 'All results of working can be shared with researchers after the study is published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}