[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659223":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":46,"overallOfficials":29,"centralContacts":61,"locations":71,"responsibleParty":88,"collaborators":29,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":29,"enrollmentInfo":102,"targetDuration":29,"studyType":105,"phases":29,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":115,"whyStopped":29,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Fundación Santa Fe de Bogota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain intensity (Visual Analog Scale)","Patient-reported pain intensity on a 0 to 10 Visual Analog Scale (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain. Self-administered through automated REDCap surveys sent by WhatsApp or email, with outcome assessors and the statistician blinded to exposure. Pain trajectories will be compared between cohorts using a linear mixed model for repeated measures (fixed effects: cohort, time and cohort-by-time interaction; patient as random effect), reporting mean between-group differences with 95% confidence intervals at each time point.","24 hours, 48 hours and 7 days after cesarean delivery",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Quality of obstetric recovery (ObsQoR-10 score)","Patient-reported quality of recovery measured with the validated Spanish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-Spanish). It includes 10 items scored 0 to 10, for a total score of 0 to 100; higher scores indicate better recovery. Self-administered through an automated REDCap survey. Compared between cohorts as a continuous variable.","24 hours after cesarean delivery",{"measure":19,"description":20,"timeFrame":17},"Proportion of participants with good obstetric recovery (ObsQoR-10 score ≥70)","Percentage of participants classified as having good recovery (ObsQoR-10 total score ≥70 points) versus poor recovery (\\\u003C70 points), using the cut-off reported in the literature. Compared between cohorts with risk ratios or odds ratios and 95% confidence intervals.",{"measure":22,"description":23,"timeFrame":24},"Time to first ambulation","Time in hours from the end of cesarean delivery until the participant walks for the first time, obtained from the medical record. Compared between cohorts as a continuous variable, and with time-to-event analysis (Kaplan-Meier, log-rank test) if exact times are available.","From end of surgery up to 24 hours after cesarean delivery",{"measure":26,"description":27,"timeFrame":28},"Use of rescue analgesia","Percentage of participants who require rescue systemic opioid analgesia in addition to the standard institutional regimen (given for a pain score \\>7 or at the patient's request), obtained from the medical record. Compared between cohorts with risk ratios or odds ratios and 95% confidence intervals, adjusted with multivariable logistic regression.","First 24 hours after cesarean delivery",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Background and rationale Intrathecal morphine is the gold standard for analgesia after cesarean delivery. However, 25-80% of women still report moderate to severe pain during the first 24-48 hours. Poorly controlled pain may delay mobilization, increase systemic opioid use, interfere with breastfeeding and newborn care, and has been associated with chronic pain and postpartum depression. International recommendations (PROSPECT, ERAS) support multimodal analgesia. Local anesthetic wound infiltration is simple, inexpensive and reproducible, but evidence on its added benefit over intrathecal morphine is limited and heterogeneous in dose, technique and anatomical plane. Levobupivacaine, the pure S-enantiomer of bupivacaine, has lower cardiovascular and central nervous system toxicity.\n\nDesign This is a prospective, single-center, analytical observational cohort study at Fundación Santa Fe de Bogotá, a high-complexity teaching hospital in Bogotá, Colombia, with about 2,000 births per year. Patients are enrolled consecutively over 10 months. Exposure is determined only by the usual clinical practice of each attending obstetrician. The investigators do not assign, randomize or suggest the exposure.\n\nExposure Exposed cohort: subcutaneous and subfascial infiltration with levobupivacaine 0.75%, 75 mg (one 10 mL ampoule diluted in 10 mL of saline), after closure of the aponeurosis. The drug is Bupinest®, INVIMA registration 2016 M-013339-R2. The total local anesthetic dose, including the spinal dose, stays within the maximum of 2 mg\u002Fkg.\n\nUnexposed cohort: no wound infiltration.\n\nStandard institutional analgesia (both cohorts) Spinal anesthesia with intrathecal morphine 100 mcg and fentanyl 25 mcg. Ketorolac 30 mg IV after delivery of the newborn. Acetaminophen 1 g IV at the end of surgery. During the 48-hour hospital stay: oral celecoxib every 12 hours (unless contraindicated), oral acetaminophen 1 g every 8 hours, and IV hyoscine butylbromide 20 mg every 8 hours.\n\nRescue systemic opioid for pain score \\>7 or at the patient's request.\n\nBlinding and data collection Outcome assessment and statistical analysis are blinded to exposure. Patient-reported outcomes (pain scale and the validated Spanish version of the ObsQoR-10) are self-administered through automated REDCap surveys sent by WhatsApp or email, which reduces inter-observer variability. Clinical and surgical data are taken from the electronic medical record.\n\nSample size Sample size was calculated with Epidat 4.2 for comparison of two independent means, using 24-hour pain scores from published data. The parameters were 95% confidence, 80% power and a 1:1 ratio. The result is 336 participants (168 per cohort).\n\nStatistical analysis Pain trajectory (24 h, 48 h, 7 days): linear mixed model for repeated measures. Fixed effects are exposure, time and the exposure × time interaction; the patient is a random effect. Mean between-group differences at each time point are reported with 95% CIs. If model assumptions are not met, robust or ordinal models will be used.\n\nSecondary outcomes:\n\nTime to first ambulation: t-test or Mann-Whitney, and Kaplan-Meier with log-rank if exact times are available.\n\nRescue analgesia: chi-square or Fisher's exact test, and logistic regression. ObsQoR-10: as a continuous score, and dichotomized at ≥70 points as good recovery.\n\nAdjusted models: multivariable models adjust for confounders, including maternal age, BMI and previous cesarean delivery.\n\nExploratory subgroups: age, parity, BMI category and previous cesarean delivery.\n\nSignificance is set at p \\\u003C0.05. The analysis will be done in Rstudio.\n\nEthics The study is classified as minimal risk under Colombian Resolution 8430 of 1993. It has been approved by the Corporate Research Ethics Committee (CCEI) of Fundación Santa Fe de Bogotá. As an observational Phase IV study of a marketed medicine, it will be notified to INVIMA, the Colombian National Food and Drug Surveillance Institute, before enrollment begins. All participants give electronic informed consent through REDCap. Results will be published regardless of direction.","Women admitted for cesarean delivery to the Obstetrics Service of Fundación Santa Fe de Bogotá, a private, high-complexity university hospital in Bogotá, Colombia, which attends approximately 2,000 births per year.",[36,42],{"label":37,"type":29,"description":38,"interventionNames":39},"Levobupivacaine wound infiltration","Women undergoing scheduled cesarean delivery under spinal anesthesia with intrathecal morphine and fentanyl whose attending obstetrician, as part of usual clinical practice, performs subcutaneous and subfascial wound infiltration with levobupivacaine 0.75% (75 mg, one 10 mL ampoule diluted in 10 mL of saline) after closure of the aponeurosis. Participants also receive standard institutional multimodal analgesia: ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Exposure is not assigned by the investigators.",[40,41],"Drug: Levobupivacaine","Drug: Intrathecal Morphine",{"label":43,"type":29,"description":44,"interventionNames":45},"No wound infiltration","Women undergoing scheduled cesarean delivery under spinal anesthesia with intrathecal morphine and fentanyl whose attending obstetrician, as part of usual clinical practice, does not perform wound infiltration with local anesthetic. Participants receive the same standard institutional multimodal analgesia: ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Exposure is not assigned by the investigators.",[41],[47,55],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Levobupivacaine","Subcutaneous and subfascial wound infiltration with levobupivacaine 0.75%, 75 mg (one 10 mL ampoule diluted in 10 mL of saline, total 20 mL), performed after closure of the aponeurosis at the end of cesarean delivery, as part of the attending obstetrician's usual practice. Given in addition to the same standard institutional multimodal analgesia received by all participants: intrathecal morphine plus fentanyl, ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Not assigned by the investigators.",[37],[53,54],"Bupinest®","Levobupivacaine hydrochloride",{"type":48,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Intrathecal Morphine","Single-dose intrathecal morphine plus fentanyl given with spinal anesthesia for cesarean delivery, as part of the standard institutional multimodal analgesia protocol (with ketorolac, acetaminophen, celecoxib and hyoscine butylbromide; systemic opioid rescue as needed).",[37,43],[60],"Spinal morphine",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":29,"email":66},"Karen D Cepeda, MD","CONTACT","+573173691828","investigador.gorh@fsfb.org.co",{"name":68,"role":64,"phone":69,"phoneExt":29,"email":70},"Camilo Hernandez, MD","+573153891355","chernandezdea@hotmail.com",[72],{"facility":73,"status":29,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Fundación Santa Fe de Bogotá","Bogotá","Bogota D.C.","111321","Colombia","CO",{"type":80,"coordinates":81},"Point",[82,83],-74.08175,4.60971,{"lat":83,"lon":82},[86,87],{"name":63,"role":64,"phone":65,"phoneExt":29,"email":66},{"name":68,"role":64,"phone":69,"phoneExt":29,"email":70},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Camilo Hernandez de Alba","Gynecologist, obstetrician, specialist in maternal-fetal medicine and fetal surgery","100659223","pain-after-scheduled-cesarean-delivery-spinal-morphine-with-or-without-levobupivacaine-wound-infiltration-100659223",false,"NCT07859956","Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration","Postoperative Pain Control After Cesarean Delivery: Intrathecal Morphine With or Without Adjunctive Fascial Levobupivacaine Infiltration. A Prospective Observational Cohort Study","LEVO-CS","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older\n* Scheduled (elective) cesarean delivery, without prior onset of labor\n* Cesarean delivery performed under spinal anesthesia with intrathecal morphine\n* Single or multiple pregnancy\n* First or subsequent birth (nulliparous or multiparous)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Exteriorization of the uterus as part of the surgical technique used by the obstetrician\n* Severe bleeding during surgery (obstetric hemorrhage) requiring management beyond medications, such as an intrauterine balloon (Bakri balloon), hemostatic sutures (e.g., B-Lynch) or hysterectomy\n* Known allergy or hypersensitivity to bupivacaine, levobupivacaine or other amide-type local anesthetics\n* Known allergy or hypersensitivity to opioids\n* Myasthenia gravis\n* Epilepsy\n* Cardiac arrhythmias\n* Shock\n* Liver damage (hepatic impairment)","FEMALE","18 Years",{"count":103,"type":104},336,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether injecting a numbing medicine (levobupivacaine, a local anesthetic) into the surgical wound at the end of a cesarean delivery improves pain control in women who also receive spinal morphine. Spinal morphine is the standard pain treatment for cesarean delivery.\n\nThe main questions it aims to answer are:\n\nDo women who receive wound infiltration with levobupivacaine report less pain at 24 hours, 48 hours, and 7 days after surgery than women who do not? Do they have a better quality of recovery, measured with the ObsQoR-10 questionnaire? Do they walk for the first time sooner, and do they need less additional (\"rescue\") pain medicine in the first 24 hours?\n\nResearchers will compare two groups of women having a scheduled cesarean delivery under spinal anesthesia at Fundación Santa Fe de Bogotá (Bogotá, Colombia). In the first group, the surgeon routinely infiltrates the wound with levobupivacaine when closing. In the second group, the surgeon does not. The study team does not decide which women receive the medicine; this depends only on each surgeon's usual practice. All participants receive the same standard hospital pain treatment: spinal morphine, acetaminophen, and anti-inflammatory medicines.\n\nParticipants will:\n\nReceive their usual cesarean care, with no extra procedures because of the study.\n\nAnswer short online questionnaires sent by WhatsApp or email at 24 hours, 48 hours, and 7 days after surgery. They will rate their pain on a 0-10 scale at each time point and their recovery with the ObsQoR-10 questionnaire at 24 hours.\n\nReceive a phone call on day 7 reminding them to complete the last questionnaire.\n\nAllow the research team to collect information from their medical record, such as the time to first walk and the use of rescue pain medicine.\n\nThe study plans to include 336 women over about 10 months.",[108,109,110,49],"Pain Management","C Section","Obstetric Pain",[112,113,49,114,108],"Cesarean Section","Pain, Postoperative","Analgesia, Obstetrical","NOT_YET_RECRUITING","2026-09-30",{"date":118,"type":119},"2026-10-06","ACTUAL",{"date":121,"type":104},"2026-10-14",{"date":123,"type":104},"2027-09-14",{"name":5,"class":6},1]