Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT05262569
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2022-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Opioid Use and Ileus Occurrence---A Case Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 596}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative opioid usage', 'timeFrame': 'Within 3 postoperative days', 'description': 'Sufentanil(μg/kg) used through patient-controlled analgesia'}], 'secondaryOutcomes': [{'measure': 'Use of transversus abdominis plane(TAP) block', 'timeFrame': 'Before surgery', 'description': 'The percentage TAP block of each group'}, {'measure': 'Patent-controlled analgesia(PCA) setting', 'timeFrame': 'Within 3 postoperative days', 'description': 'The percentage of PCA setting with basal infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ileus', 'opioid use', 'enhanced recovery after surgery', 'colorectal surgery'], 'conditions': ['Ileus', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '31082966', 'type': 'BACKGROUND', 'citation': 'Wu CL, King AB, Geiger TM, Grant MC, Grocott MPW, Gupta R, Hah JM, Miller TE, Shaw AD, Gan TJ, Thacker JKM, Mythen MG, McEvoy MD; Fourth Perioperative Quality Initiative Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Perioperative Opioid Minimization in Opioid-Naive Patients. Anesth Analg. 2019 Aug;129(2):567-577. doi: 10.1213/ANE.0000000000004194.'}, {'pmid': '18305994', 'type': 'BACKGROUND', 'citation': 'Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.'}, {'pmid': '11755892', 'type': 'BACKGROUND', 'citation': 'Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001 Nov;182(5A Suppl):11S-18S. doi: 10.1016/s0002-9610(01)00782-6.'}, {'pmid': '21343919', 'type': 'BACKGROUND', 'citation': 'Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011 May;106(5):835-42; quiz 843. doi: 10.1038/ajg.2011.30. Epub 2011 Feb 22.'}, {'pmid': '27687384', 'type': 'BACKGROUND', 'citation': 'Ahn JH, Ahn HJ. Effect of thoracic epidural analgesia on recovery of bowel function after major upper abdominal surgery. J Clin Anesth. 2016 Nov;34:247-52. doi: 10.1016/j.jclinane.2016.04.042. Epub 2016 May 13.'}, {'pmid': '28059913', 'type': 'BACKGROUND', 'citation': 'Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.'}, {'pmid': '31797098', 'type': 'BACKGROUND', 'citation': 'Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4.'}, {'pmid': '27005290', 'type': 'BACKGROUND', 'citation': 'Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22.'}, {'pmid': '19542795', 'type': 'BACKGROUND', 'citation': 'Chen JY, Ko TL, Wen YR, Wu SC, Chou YH, Yien HW, Kuo CD. Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. Clin J Pain. 2009 Jul-Aug;25(6):485-9. doi: 10.1097/AJP.0b013e31819a506b.'}, {'pmid': '29352454', 'type': 'BACKGROUND', 'citation': 'Aryaie AH, Lalezari S, Sergent WK, Puckett Y, Juergens C, Ratermann C, Ogg C. Decreased opioid consumption and enhance recovery with the addition of IV Acetaminophen in colorectal patients: a prospective, multi-institutional, randomized, double-blinded, placebo-controlled study (DOCIVA study). Surg Endosc. 2018 Aug;32(8):3432-3438. doi: 10.1007/s00464-018-6062-y. Epub 2018 Jan 19.'}, {'pmid': '33262644', 'type': 'BACKGROUND', 'citation': 'Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.'}, {'pmid': '25724094', 'type': 'BACKGROUND', 'citation': 'Vather R, Josephson R, Jaung R, Robertson J, Bissett I. Development of a risk stratification system for the occurrence of prolonged postoperative ileus after colorectal surgery: a prospective risk factor analysis. Surgery. 2015 Apr;157(4):764-73. doi: 10.1016/j.surg.2014.12.005. Epub 2015 Feb 25.'}, {'pmid': '23689489', 'type': 'BACKGROUND', 'citation': 'Vather R, Bissett IP. Risk factors for the development of prolonged post-operative ileus following elective colorectal surgery. Int J Colorectal Dis. 2013 Oct;28(10):1385-91. doi: 10.1007/s00384-013-1704-y. Epub 2013 May 21.'}, {'pmid': '28285365', 'type': 'BACKGROUND', 'citation': 'Grass F, Slieker J, Jurt J, Kummer A, Sola J, Hahnloser D, Demartines N, Hubner M. Postoperative ileus in an enhanced recovery pathway-a retrospective cohort study. Int J Colorectal Dis. 2017 May;32(5):675-681. doi: 10.1007/s00384-017-2789-5. Epub 2017 Mar 11.'}, {'pmid': '27806440', 'type': 'BACKGROUND', 'citation': "Yuan L, O'Grady G, Milne T, Jaung R, Vather R, Bissett IP. Prospective comparison of return of bowel function after left versus right colectomy. ANZ J Surg. 2018 Apr;88(4):E242-E247. doi: 10.1111/ans.13823. Epub 2016 Nov 2."}, {'pmid': '27542335', 'type': 'BACKGROUND', 'citation': 'Kim IK, Kang J, Baik SH, Lee KY, Kim NK, Sohn SK. Impact of prior abdominal surgery on postoperative prolonged ileus after ileostomy repair. Asian J Surg. 2018 Jan;41(1):86-91. doi: 10.1016/j.asjsur.2016.07.006. Epub 2016 Aug 17.'}, {'pmid': '23389068', 'type': 'BACKGROUND', 'citation': 'Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.'}, {'pmid': '30426190', 'type': 'BACKGROUND', 'citation': 'Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.'}, {'pmid': '30332482', 'type': 'BACKGROUND', 'citation': 'Zhen L, Li X, Gao X, Wei H, Lei X. Dose determination of sufentanil for intravenous patient-controlled analgesia with background infusion in abdominal surgeries: A random study. PLoS One. 2018 Oct 17;13(10):e0205959. doi: 10.1371/journal.pone.0205959. eCollection 2018.'}, {'pmid': '37096402', 'type': 'DERIVED', 'citation': 'Ju H, Shen K, Li J, Feng Y. Total postoperative opioid dose is an independent risk factor for prolonged postoperative ileus after laparoscopic colorectal surgery: a case-control study. Korean J Anesthesiol. 2024 Feb;77(1):133-138. doi: 10.4097/kja.22792. Epub 2023 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative ileus (POI) is a significant complication after colorectal surgery, with reported incidence ranging from 10\\~30%, leading to increased morbidity, hospital length of stay, and thus medical cost. To determine the risk factors for POI is one of the key elements for Enhanced Recovery after Surgery protocol. Increased perioperative opioid usage has been proposed as an independent risk factor for postoperative ileus, as perioperative opioid minimization has proposed to be an effective measure to decrease the incidence of POI. Although opioids are widely used to attenuate stress during surgery, and represent the cornerstone of pain treatment, anesthesiologists are strive to minimize opioid use to decrease opioid-related GI side effects. In this study, the investigators aim to find out the general occurrence of POI in the laparoscopic colorectal surgery and the effects of the postoperative opioid usage on this outcome. The strategies of opioid minimization was also investigated.', 'detailedDescription': "2.1 Study design For this case-control study, all elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database. The study protocol was approved by the Institutional Review Board of Peking University People's Hospital (2021PHB144-001, May 24, 2021), Beijing, China, and informed consent was waived due to the retrospective design.\n\nThe anesthesia medical information system was searched for patients aged 18 years old and above, undergoing elective laparoscopic colorectal procedures who received patient controlled intravenous analgesia postoperatively. Patients were excluded if they had chronic opioid use, converted to open, admitted to intensive care unit(ICU), patient controlled analgesia (PCA) regimens other than sufentanil, PCA used shorter than 48 hours, or incomplete postoperative opioid usage record. Patients were followed up until discharge from the hospital.\n\n2.2 Patient allocation Patients who experienced postoperative ileus were included in ileus group. In accordance with the definition of Vather et al, diagnosis of postoperative ileus required 2 or more of following persistent symptoms on the fourth postoperative day and onward: nausea and vomiting, inability to tolerate solid or semi-liquid diet or failure to pass gas or stool during a 24 hour period, abdominal distension and radiological evidence of ileus. Patient charts, including radiographs were evaluated retrospectively. Diagnosis of an ileus was confirmed clinically and radiographically in all cases. The control group (at a 1:1 ratio) was matched by selecting the same range of age (±5 years of age), the same grade of American Society of Anesthesiology(ASA) classification, and the same types of surgery (colectomy, rectectomy, whole colon resection, or others).\n\n2.3 Perioperative management All patients received standard anesthesia protocol for laparoscopic colorectal procedures within Peking University People's Hospital. Patients might received bilateral transversus abdominis plane(TAP) blocks (0.3% Ropivacaine of 30\\~40ml under the ultrasound guidance) at the discretion of the anesthesiologist in charge.\n\nGeneral anesthesia was induced using etomidate (0.2-0.6 mg/kg) and sufentanil (0.3 μg/kg) and maintained with continuous infusion of propofol (4-6 mg/kg/h) to target a bispectral index of 40-60. Cisatracurium (0.15 mg/kg) was injected intravenously to facilitate endotracheal intubation. Intravenous sufentanil (0.1 μg/kg) was added before skin incision. During surgery, continuous infusion of remifentanil (0.1-0.2 μg /kg/min) was adjusted to keep heart rate (HR) and mean arterial blood pressure (MAP) within 80-120% of baseline. Hypotension (MAP \\< 80% of baseline) lasting for 3 min was managed with a bolus of 6 mg of ephedrine or 50 μg of phenylephrine. Bradycardia (HR \\< 45/min) was treated with atropine (0.25-0.5 mg). At the end of surgery, neostigmine (1 mg) and atropine (0.5 mg) were used to antagonize neuromuscular blockade, and tracheal extubation was performed when the patient was fully awake and breathing adequately. Patients were transferred to the post-anesthesia care unit (PACU) and discharged when the Modified Aldrete Score reached 10.\n\n2.4 Postoperative pain management Postoperative pain management was charged by the acute pain service(APS). Acute pain or side effects related to the opioid was managed through the setting of intravenous patient-controlled analgesia(PCA) device. Patients received intravenous, intramuscular or oral analgesic rescue only after the PCA withdrawal.\n\nIn general, a patient-controlled analgesia (PCA) device was attached after tracheal extubation. The PCA was set to provide a bolus of 2\\~3μg sufentanil (1 μg/ml) with a lockout time of 10\\~15 min with or without basal infusion, 2\\~3ml/h (sufentanil 1μg/ml), which was set at the discretion of the anesthesiologist in charge according to the patient's age and weight. After surgery, pain score was verbally rated using the 11-point numeric rating scale (NRS), on which 0 indicates no pain and 10 indicates worst imaginable pain. Patients could self-administer intravenous sufentanil bolus via PCA (2\\~3μg, 1 μg/ml) postoperatively as rescue analgesia when the NRS score was ≥4, or as needed. PCA was maintained for at least the first 48 h after surgery.\n\n2.5 Study outcomes and measurements Multiple potential risk factors for POI were considered based on literature review. Baseline factors included age(matched), gender, BMI, presence of major comorbidities (cardiovascular diseases, cerebral diseases, pulmonary diseases, or diabetes), ASA classification (matched), and previous abdominal surgery. Operative factors included type of surgery(matched), length of the surgery, estimated blood loss, total input, time to pass stool in patients' without enterostomy, time to tolerance of oral diet, and postoperative length of hospital stay. Analgesia related risk factors included TAP block, intra-operative opioid use(converted into equivalent doses of morphine, mg/kg), postoperative day 1 (POD1) and total post-operative opioid (Sufentanil, μg/kg), and PCA setting (with or without basal infusion). Postoperative NRS at rest and when coughing were recorded. Adverse events occurring prior to discharge were also collected from the hospital chart.\n\n2.6 Statistical analysis Statistical analysis was performed using the SPSS statistical software package (SPSS Inc., Chicago, IL). Continuous variables are expressed as mean ± standard deviation(SD) or medians with interquartile range and categorical variables as numbers and percentages. Between-group differences were evaluated using the independent t test or Mann-Whitney U test for continuous variables and the χ2 test or Fisher exact test for categorical variables, as appropriate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years old and above\n* Underwent elective laparoscopic colorectal procedures\n* Received patient controlled intravenous analgesia postoperatively\n\nExclusion Criteria:\n\n* Chronic opioid use\n* Converted to open\n* Admitted to ICU\n* PCA regimens other than sufentanil\n* PCA used shorter than 48 hours\n* Incomplete postoperative opioid usage record'}, 'identificationModule': {'nctId': 'NCT05262569', 'briefTitle': 'Postoperative Opioid Use and Ileus Occurrence---A Case Control Study', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Increased Postoperative Opioid Use is a Risk Factor for an Ileus After Laparoscopic Colorectal Surgery---A Case Control Study', 'orgStudyIdInfo': {'id': 'Opioid and postoperative POI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ileus group', 'description': 'Patients developed postoperative ileus', 'interventionNames': ['Other: ileus']}, {'label': 'control group', 'description': 'Patients did not develop postoperative ileus'}], 'interventions': [{'name': 'ileus', 'type': 'OTHER', 'description': 'retrospectively allocation according to a postoperative outcome-ileus', 'armGroupLabels': ['ileus group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Juhui, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital, Beijing, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It need to be discussed within the study group when the results are clear.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Juhui', 'investigatorAffiliation': "Peking University People's Hospital"}}}}