Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04988893
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Recovery Scores in Parturients With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-15', 'releaseDate': '2023-08-29'}, {'resetDate': '2025-03-20', 'releaseDate': '2025-03-04'}], 'estimatedResultsFirstSubmitDate': '2023-08-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], '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': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Obstetric Quality of Recovery Score (ObsQoR-10)', 'timeFrame': '24 hours post cesarean delivery', 'description': '10-item questionnaire applied to subjects 24 hours after spinal anesthesia. Measured in a 0-100 scale where 0=poor recovery and 100=perfect recovery'}], 'secondaryOutcomes': [{'measure': 'Difference in Average Numeric Rating Score (0-10 , where 0=no pain and 10= maximum pain) at specific time points in the first 24 hours', 'timeFrame': 'Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery', 'description': 'This is defined as the between- group difference in the mean pain scores on a 0-10 Numeric Rating Scale, as assessed by one of the investigators immediately after surgery (in the Post-Anaesthesia Care Unit) and every 4 hours up to 24 hours after surgery'}, {'measure': 'Opioid Consumption in the first 24 hours', 'timeFrame': '24 hours post cesarean delivery', 'description': 'Between-group difference in the total amount of Oral Morphine Equivalents consumed in the first 24 hours after surgery.'}, {'measure': 'Total Inpatient Opioid Consumption', 'timeFrame': 'up to 1 week post operatively', 'description': 'Between-group difference in the total amount of Oral Morphine Equivalents consumed during hospital stay.'}, {'measure': 'Time-to-first oral opioid analgesic request', 'timeFrame': 'Measured in hours from the time of cesarean delivery until patient request for prescribed oral opioid analgesia, up to 24 hours from the spinal anesthetic', 'description': 'This is defined as the length of time between cesarean delivery and the first time the subject requested additional opioid analgesia'}, {'measure': 'Respiratory Depression', 'timeFrame': 'In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery', 'description': 'This is defined as respiratory rate\\<8 breaths/minute, need for naloxone or need for clinical intervention.'}, {'measure': 'Nausea and/or Vomiting that required treatment', 'timeFrame': 'Absolute number of treatments required in the 24-hour time frame', 'description': 'Nausea/Vomiting episodes that required pharmacological treatment in the first 24 hours post operatively'}, {'measure': 'Pruritus that required treatment', 'timeFrame': 'Absolute number of treatments required in the 24-hour time frame.', 'description': 'Pruritus episodes that required pharmacological treatment in the first 24 hours post operatively'}, {'measure': 'Breastfeeding', 'timeFrame': '24 hours post cesarean delivery', 'description': 'Mother breastfeeding at 24 hours: Yes or No'}, {'measure': 'Time to fist mobilization', 'timeFrame': 'Measured in hours from the time of cesarean delivery until patient first mobilizes post operatively, up to 48 hours post operatively.', 'description': 'Time to fist mobilization (standing and walking independently): measured in hours'}, {'measure': 'Time to first oral intake', 'timeFrame': 'Measured in hours from the time of cesarean delivery, up to 48 hours post operatively', 'description': 'Time to first oral intake (non-clear fluids): measured in hours'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours)', 'description': 'Length of hospital stay: measured in hours.'}, {'measure': 'Unplanned Readmission Rates', 'timeFrame': '6 weeks post op', 'description': 'Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section', 'Parturients', 'Morbid Obesity'], 'conditions': ['Quality of Recovery', 'Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '16302012', 'type': 'BACKGROUND', 'citation': 'Vincent HK, Taylor AG. Biomarkers and potential mechanisms of obesity-induced oxidant stress in humans. Int J Obes (Lond). 2006 Mar;30(3):400-18. doi: 10.1038/sj.ijo.0803177.'}, {'pmid': '17494057', 'type': 'BACKGROUND', 'citation': 'Musaad S, Haynes EN. Biomarkers of obesity and subsequent cardiovascular events. Epidemiol Rev. 2007;29:98-114. doi: 10.1093/epirev/mxm005. Epub 2007 May 10.'}, {'pmid': '19423369', 'type': 'BACKGROUND', 'citation': 'Mei W, Seeling M, Franck M, Radtke F, Brantner B, Wernecke KD, Spies C. Independent risk factors for postoperative pain in need of intervention early after awakening from general anaesthesia. Eur J Pain. 2010 Feb;14(2):149.e1-7. doi: 10.1016/j.ejpain.2009.03.009. Epub 2009 May 6.'}, {'pmid': '16857442', 'type': 'BACKGROUND', 'citation': 'Gletsu N, Lin E, Zhu JL, Khaitan L, Ramshaw BJ, Farmer PK, Ziegler TR, Papanicolaou DA, Smith CD. Increased plasma interleukin 6 concentrations and exaggerated adipose tissue interleukin 6 content in severely obese patients after operative trauma. Surgery. 2006 Jul;140(1):50-7. doi: 10.1016/j.surg.2006.01.018.'}, {'pmid': '19723556', 'type': 'BACKGROUND', 'citation': 'Galic S, Oakhill JS, Steinberg GR. Adipose tissue as an endocrine organ. Mol Cell Endocrinol. 2010 Mar 25;316(2):129-39. doi: 10.1016/j.mce.2009.08.018. Epub 2009 Aug 31.'}, {'pmid': '21654297', 'type': 'BACKGROUND', 'citation': 'Kim MG, Yook JH, Kim KC, Kim TH, Kim HS, Kim BS, Kim BS. Influence of obesity on early surgical outcomes of laparoscopic-assisted gastrectomy in gastric cancer. Surg Laparosc Endosc Percutan Tech. 2011 Jun;21(3):151-4. doi: 10.1097/SLE.0b013e318219a57d.'}, {'pmid': '30876992', 'type': 'BACKGROUND', 'citation': 'Elsamadicy AA, Camara-Quintana J, Kundishora AJ, Lee M, Freedman IG, Long A, Qureshi T, Laurans M, Tomak P, Karikari IO. Reduced Impact of Obesity on Short-Term Surgical Outcomes, Patient-Reported Pain Scores, and 30-Day Readmission Rates After Complex Spinal Fusion (>/=7 Levels) for Adult Deformity Correction. World Neurosurg. 2019 Jul;127:e108-e113. doi: 10.1016/j.wneu.2019.02.165. Epub 2019 Mar 12.'}, {'pmid': '26656059', 'type': 'BACKGROUND', 'citation': 'Sorimachi Y, Neva MH, Vihtonen K, Kyrola K, Iizuka H, Takagishi K, Hakkinen A. Effect of Obesity and Being Overweight on Disability and Pain After Lumbar Fusion: An Analysis of 805 Patients. Spine (Phila Pa 1976). 2016 May;41(9):772-7. doi: 10.1097/BRS.0000000000001356.'}, {'pmid': '30739072', 'type': 'BACKGROUND', 'citation': 'Kruger MT, Naseri Y, Hohenhaus M, Hubbe U, Scholz C, Klingler JH. Impact of morbid obesity (BMI > 40 kg/m2) on complication rate and outcome following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Clin Neurol Neurosurg. 2019 Mar;178:82-85. doi: 10.1016/j.clineuro.2019.02.004. Epub 2019 Feb 4.'}, {'pmid': '29796284', 'type': 'BACKGROUND', 'citation': "Bui AH, Feldman DL, Brodman ML, Shamamian P, Kaleya RN, Rosenblatt MA, D'Angelo D, Somerville D, Mudiraj S, Kischak P, Leitman IM. Provider preferences for postoperative analgesia in obese and non-obese patients undergoing ambulatory surgery. J Pharm Policy Pract. 2018 May 17;11:9. doi: 10.1186/s40545-018-0138-x. eCollection 2018."}, {'pmid': '30579408', 'type': 'BACKGROUND', 'citation': 'Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.'}, {'pmid': '30885691', 'type': 'BACKGROUND', 'citation': 'Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2.'}, {'pmid': '32203873', 'type': 'BACKGROUND', 'citation': 'Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.'}, {'pmid': '31429919', 'type': 'BACKGROUND', 'citation': 'Sharawi N, Klima L, Shah R, Blake L, Carvalho B, Sultan P. Evaluation of patient-reported outcome measures of functional recovery following caesarean section: a systematic review using the consensus-based standards for the selection of health measurement instruments (COSMIN) checklist. Anaesthesia. 2019 Nov;74(11):1439-1455. doi: 10.1111/anae.14807. Epub 2019 Aug 20.'}, {'pmid': '33395109', 'type': 'BACKGROUND', 'citation': 'Sultan P, Carvalho B. Postpartum recovery: what does it take to get back to a baseline? Curr Opin Obstet Gynecol. 2021 Apr 1;33(2):86-93. doi: 10.1097/GCO.0000000000000684.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/mediacentre/factsheets/fs311/en/', 'label': 'WHO. Fact Sheet: Obesity and overweight. 2006.'}, {'url': 'https://www.sealedenvelope.com/power/continuous-superiority/', 'label': '17\\. Sealed Envelope Ltd. 2012. Power calculator for continuous outcome superiority trial'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of obesity has increased dramatically recently. Obesity is a pro-inflammatory state which leads to chronic low grade inflammation having different systemic effects. This may make obesity an independent risk factor for severe acute postoperative pain. No prospective studies have been conducted to specifically evaluate the quality of recovery after caesarean delivery for women with morbid obesity when compared to non-obese parturients. In addition, while there is biological plausibility to infer worse pain scores in parturients with obesity, the magnitude of this difference is unknown and information guiding adjustments in pain management are lacking.', 'detailedDescription': 'The prevalence of obesity has increased dramatically over the recent past in both developed and developing countries.\n\nObesity is a pro-inflammatory state which leads to chronic low grade inflammation. It has been well studied that this very inflammation and oxidative stress is responsible for cardiovascular pathologies seen in these patients. As a result, the post-operative period is characterized by a phase of prolonged systemic inflammatory response, which makes obesity an independent risk factor for severe acute pain. As a matter of fact, an extreme rise in IL-6 in patients with obesity has been demonstrated post-operatively.\n\nIn addition, adipose tissue acts as an endocrine organ by releasing a number of other pro-inflammatory proteins. Cytokines are known to promote various metabolic, hemodynamic and immunologic changes post-surgery, and in the setting of exaggerated inflammatory response can lead to increased pain and hemodynamic instability.\n\nVery few studies have evaluated the recovery experience of patients with obesity in the acute postoperative period. Patients with obesity undergoing general abdominal surgery have been shown to have worse surgical outcomes, increased complication rates, and increased analgesic requirements.7 However, in spine surgery, there have been conflicting evidence supporting a difference in pain scores in patients with obesity. Despite there being no clear guidelines on post-operative pain control between these two groups, providers reported prescribing less opioid analgesics post-operatively to patients with obesity when compared to patients not suffering from this condition.\n\nThe Obstetric Quality of Recovery Score (ObsQoR) was initially developed and validated as a measure of patient reported outcome after caesarean delivery. It started as an 11-item questionnaire (ObsQoR-11), which was further simplified to 10-items (ObsQoR-10) following patient feedback where moderate and severe pain questions were combined into a single item. This tool measures pain, nausea or vomiting, dizziness, shivering, comfort, mobility, ability to hold and feed the baby, personal hygiene maintenance, and feeling in control, to provide a global inpatient postpartum quality of recovery score out of 100. A systematic review assessing measurement properties of available patient-reported outcome measures using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology, recommended ObsQoR as the best available instrument to measure functional recovery following caesarean delivery.\n\nNo prospective studies have been conducted to specifically evaluate the quality of recovery after caesarean delivery for women with morbid obesity when compared to non-obese parturients. In addition, while there is biological plausibility to infer worse pain scores in parturients with obesity, the magnitude of this difference is unknown and information guiding adjustments in pain management are lacking.\n\nThe investigators hypothesize that parturients with Class 3 obesity experience impaired quality of recovery scores after elective cesarean delivery as measured by the ObsQoR-10 when compared to non-obese parturients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women meeting inclusion and exclusion criteria who are scheduled to have their Caesarean Section at Victoria Hospital, London Health Sciences Centre will be consented for participation in the study. Patients will be recruited from obstetrical and preadmission clinics at LHSC Victoria Hospital, as well as at admission for Caesarean Section to the Obstetrical Care Unit. Patients will be recruited only when inclusion criteria are fulfilled, in the absence of exclusion criteria, and after informed consent has been obtained.', 'genderDescription': 'Female subjects currently pregnant undergoing elective cesarean delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Term pregnancy (\\> 37 weeks gestational age)\n* Elective caesarean delivery\n* BMI \\>40 (Study Group) or BMI \\<30 (Control Group)\n* ASA\\<=3\n\nExclusion Criteria:\n\n* Chronic pain\n* History of opioid use during pregnancy.\n* History of substance abuse disorder during pregnancy.\n* Contraindication to neuraxial opioids, acetaminophen and/or NSAIDs\n* Language barrier\n* Allergy to Opioids or NSAIDS\n* Intra-operative conversion to general anesthesia\n* Maternal Admission to ICU.\n* Neonatal admission to NICU.'}, 'identificationModule': {'nctId': 'NCT04988893', 'briefTitle': 'Quality of Recovery Scores in Parturients With Obesity', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Quality of Recovery Scores in Parturients With Obesity: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '11292'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parturients with Normal Weight', 'description': 'Parturients undergoing elective caesarean delivery with a BMI \\<30 (control group)'}, {'label': 'Parturients with Morbid Obesity', 'description': 'Parturients undergoing elective caesarean delivery with a BMI \\>40 (Study Group)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Ilana Sebbag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-29', 'type': 'RELEASE'}, {'date': '2024-03-15', 'type': 'RESET'}, {'date': '2025-03-04', 'type': 'RELEASE'}, {'date': '2025-03-20', 'type': 'RESET'}], 'unpostedResponsibleParty': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}