Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT03761433
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2018-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Nociception and Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The expectation of postoperative pain', 'timeFrame': 'The day before surgery', 'description': 'The postoperative pain score (numeric rating pain score, no pain=0\\~ worst pain=10)'}, {'measure': 'The expectation of analgesics consumption', 'timeFrame': 'The day before surgery', 'description': 'less than average, average, more than average'}], 'primaryOutcomes': [{'measure': 'The requirement of postoperative analgesics for postoperative 24 hours', 'timeFrame': 'postoperative 24 hour', 'description': 'The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)'}, {'measure': 'The immediate postoperative pain score', 'timeFrame': 'postoperative 24 hour', 'description': 'The numeric rating pain score, no pain=0 \\~ worst pain=10'}, {'measure': 'intraoperative nociception score (surgical pleth index)', 'timeFrame': 'intraoperative at the time of skin incision', 'description': 'under End tidal sevoflurane 3%, surgical pleth index score following surgical incision'}], 'secondaryOutcomes': [{'measure': 'The correlation of requirement of summed postoperative analgesics and intraoperative nociception score', 'timeFrame': 'postoperative 1 hour', 'description': 'The consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value'}, {'measure': 'The correlation of highest postoperative pain score and intraoperative nociception score', 'timeFrame': 'postoperative 1 hour', 'description': 'The postoperative pain score (numeric rating pain score, no pain=0\\~ worst pain=10)and intraoperative surgical pleth index score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Nociceptive Pain', 'Analgesics']}, 'referencesModule': {'references': [{'pmid': '30390161', 'type': 'BACKGROUND', 'citation': 'Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2.'}, {'pmid': '23290256', 'type': 'BACKGROUND', 'citation': 'Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.'}, {'pmid': '27543532', 'type': 'BACKGROUND', 'citation': 'Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.'}, {'pmid': '28678075', 'type': 'BACKGROUND', 'citation': 'Baron-Stefaniak J, Gotz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plochl W. Patients Undergoing Orthotopic Liver Transplantation Require Lower Concentrations of the Volatile Anesthetic Sevoflurane. Anesth Analg. 2017 Sep;125(3):783-789. doi: 10.1213/ANE.0000000000002250.'}]}, 'descriptionModule': {'briefSummary': "If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the relation intraoperative nociception response with postoperative pain score.\n\nIn similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index values for stimulus of skin incision are thought to reflect the individual nociception characteristics.", 'detailedDescription': 'Patients who undergoing upper abdominal laparotomy surgery usually experience severe postoperative pain. Previous studies were reported that preoperative pain, young age, high-dose remifentanil, and depression were associated with severe postoperative pain.\n\nHowever, anesthesia-related studies were either retrospective studies or injected with anesthetic agents in excess of clinical doses to differentiate between groups. There is no objective indicator for prediction severe postoperative pain.The purpose of this study was to investigate the relationship between intraoperative pain response and postoperative pain on standardized surveillance devices.\n\nTo maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used. Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive pain-analgesia balance monitoring device that is commercially available to evaluate the state of pain during general anesthesia. SPI = 100- (0.3 \\* heart beat interval + 0.7 \\* photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation.\n\nIn similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of skin incision are thought to reflect the individual nociception characteristics. The investigators hypothesized the higher analgesics consumption can predict with high SPI response following incisional stimuli.\n\nThus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth, hemodynamically stable and appropriate anesthetic depth based on previous studies were confirmed at the time of skin incision). And the characteristics and emotional status of patients in two groups are compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the 20-80 year old patients who undergoing lapatotomy gastrectomy at samsung medical center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-undergoing laparotomy gastrectomy\n\nExclusion Criteria:\n\n* cardiac arrythmia\n* allergic history for drugs\n* renal failure (Cr\\> 1.5 mg/dl)'}, 'identificationModule': {'nctId': 'NCT03761433', 'briefTitle': 'Intraoperative Nociception and Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy', 'orgStudyIdInfo': {'id': 'SMC2018-11-118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPI group', 'description': 'All patients who received the liver resection surgery will receive surgical pleth index', 'interventionNames': ['Device: SPI group']}], 'interventions': [{'name': 'SPI group', 'type': 'DEVICE', 'description': 'All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%', 'armGroupLabels': ['SPI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}