[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658581":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":37,"overallOfficials":25,"centralContacts":43,"locations":25,"responsibleParty":49,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":25,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":25,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":25},{"fullName":5,"class":6},"Fundación Santa Fe de Bogota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Pain Intensity on the Numeric Rating Scale (NRS)","Pain intensity measured on the 0 to 10 Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain; higher scores indicate worse pain) as documented in the electronic health record. Baseline is the value recorded closest to infusion start within the 24 hours before; post-infusion values are those recorded closest to 24 and 48 hours after infusion start. The absolute change (post-infusion minus baseline) will be reported.","Baseline (within 24 hours before infusion start), 24 hours and 48 hours after infusion start",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Percentage of Patients With a Clinically Meaningful Analgesic Response","Analgesic response is defined as a reduction of 2 or more points on the 0 to 10 Numeric Rating Scale (NRS) or a reduction of 30% or more from the baseline NRS within the first 24 to 48 hours after infusion start. The percentage of responders will be reported with its 95% confidence interval.","24 to 48 hours after infusion start",{"measure":19,"description":20,"timeFrame":12},"Change in Opioid Requirements in Oral Morphine Milligram Equivalents per 24 Hours (MME\u002F24 h)","Total daily opioid dose converted to oral morphine milligram equivalents (MME\u002F24 h). Baseline is the value within the 24 hours before infusion start; post-infusion values are those closest to 24 and 48 hours after infusion start. The absolute change (post-infusion minus baseline) will be reported.",{"measure":22,"description":23,"timeFrame":24},"Number of Patients With Adverse Events Attributed to Lidocaine","Frequency, type (dizziness, nausea, somnolence, paresthesia, hypotension, arrhythmia, seizure, central nervous system toxicity, other) and clinical severity of adverse events documented in the medical record as attributable to the lidocaine infusion.","From infusion start until the end of the infusion",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","RETROSPECTIVE","Background: Malignant bowel obstruction (MBO) occurs in 10 to 28% of patients with gastrointestinal cancers and in up to 51% of patients with advanced ovarian cancer. Pain is present in 70 to 90% of patients and is often multifactorial, with visceral, inflammatory and neuropathic components. International supportive care guidelines recommend opioids as the basis of analgesic treatment, together with adjuvants, antisecretory agents and antiemetics. However, a subgroup of patients develops refractory pain or dose-limiting opioid adverse effects. Lidocaine, a voltage-gated sodium channel blocker with additional activity at muscarinic and NMDA receptors, has been used as an adjuvant infusion for refractory cancer pain, but evidence specific to MBO is scarce.\n\nDesign: Single-center, observational, retrospective cohort study with descriptive and analytical components, conducted in the context of routine clinical practice. Data sources are the institutional electronic health records.\n\nPopulation and identification: Adults (18 years or older) with cancer and MBO attended by the palliative care team between 2015 and 2025 who received a lidocaine infusion with analgesic intent. Patients will be identified through institutional databases, palliative care service records and medical orders for lidocaine infusions prescribed by a pain and palliative care specialist or fellow. All consecutive eligible patients will be included (non-probability, convenience sample). Eligibility will be verified in the electronic health record by the research team.\n\nData collection: Data will be recorded in an institutional REDCap database with a unique pseudonymized code for each participant. Variables include demographic, clinical and oncological characteristics (primary tumor, stage, peritoneal carcinomatosis, active cancer treatment, ECOG performance status), obstruction characteristics (level, grade, diagnostic method), pain type, baseline opioid use and oral morphine milligram equivalents (MME\u002F24 h), concomitant adjuvant treatments (corticosteroids, somatostatin analogues, anticholinergics, ketamine, gabapentinoids), lidocaine regimen (route, initial and maximum dose in mg\u002Fkg\u002Fh, duration), pain intensity (0 to 10 Numeric Rating Scale, NRS) before and after infusion start, adverse events, reason for infusion discontinuation and hospital discharge destination.\n\nTime windows: Baseline NRS and MME are those recorded within the 24 hours before infusion start; post-infusion values are those recorded at 24 and\u002For 48 hours after infusion start, using the value closest to each time point.\n\nOutcomes: The primary outcome is the change in pain intensity (NRS) from baseline to 24 to 48 hours after infusion start. Secondary outcomes include the proportion of analgesic responders (reduction of 2 or more NRS points or 30% or more from baseline within 24 to 48 hours), change in MME\u002F24 h, frequency and type of adverse events, discontinuation due to toxicity, lidocaine dosing and duration, and hospital discharge destination.\n\nStatistical analysis: Categorical variables will be summarized as frequencies and proportions and continuous variables as means with standard deviations or medians with interquartile ranges according to their distribution. Paired pre-post comparisons of NRS and MME will use the paired t test or the Wilcoxon signed-rank test as appropriate. The proportion of responders will be reported with 95% confidence intervals. Exploratory subgroup analyses (lidocaine dose, infusion duration, route, baseline pain, ECOG and baseline MME) will use chi-square or Fisher exact tests and t, Mann-Whitney U or Kruskal-Wallis tests as appropriate. Missing data will be described; complete-case analysis will be used if missingness is below 10%, and multiple imputation will be considered otherwise. Given the absence of an external control group and the potential for confounding by indication, all findings will be interpreted as associations without causal inference.\n\nEthics: The study is classified as minimal risk under Colombian Resolution 8430 of 1993. The protocol (version 1.0, February 18, 2026), including a waiver of informed consent for retrospective record review, was approved by the Comité Corporativo de Ética en Investigación of Fundación Santa Fe de Bogotá (CCEI-19342-2026). Data will be handled in accordance with Colombian Law 1581 of 2012 on personal data protection.","Adults (18 years or older) with cancer and malignant bowel obstruction attended by the palliative care team at Hospital Universitario Fundación Santa Fe de Bogotá (Bogotá, Colombia) between 2015 and 2025 who received an intravenous or subcutaneous lidocaine infusion as adjuvant pain treatment in routine clinical practice. Patients will be identified through institutional databases, palliative care service records and medical orders for lidocaine infusions.",[32],{"label":33,"type":25,"description":34,"interventionNames":35},"Lidocaine Infusion Cohort","Adults with cancer and malignant bowel obstruction who received an intravenous or subcutaneous lidocaine infusion as adjuvant analgesia in routine clinical practice between 2015 and 2025. Pain intensity and opioid requirements before and after infusion start will be compared within patients; there is no external control group.",[36],"Drug: Lidocaine",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":25},"DRUG","Lidocaine","Continuous intravenous or subcutaneous lidocaine infusion administered with analgesic intent as adjuvant pain treatment in routine clinical practice, with dose, route and duration determined by the treating team. The study does not assign or modify treatment; exposure data are abstracted retrospectively from medical records.",[33],[44],{"name":45,"role":46,"phone":47,"phoneExt":25,"email":48},"Juan Guillermo Santacruz Escudero, MD, Internist, Palliative care","CONTACT","+57 601 6030303","juan.santacruz@fsfb.org.co",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Juan Guillermo Santacruz Escudero","MD, Internist, Pain and Palliative Care Specialist","100658581","lidocaine-infusions-for-pain-in-patients-with-malignant-bowel-obstruction-100658581",false,"NCT07856251","Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction","Use of Lidocaine Infusions for Pain Management in Patients With Malignant Bowel Obstruction at Hospital Universitario Fundación Santa Fe de Bogotá: A Retrospective Cohort Study","Inclusion Criteria:\n\n* Adults aged 18 years or older with a diagnosis of cancer.\n* Diagnosis of malignant bowel obstruction confirmed by clinical criteria and\u002For imaging studies and documented in the medical record.\n* Moderate to severe or refractory pain documented with the Numeric Rating Scale (NRS), ideally with a baseline NRS recorded within the 24 hours before infusion start and at least one NRS recorded within 24 to 48 hours after infusion start.\n* Receipt of a lidocaine infusion with analgesic intent as adjuvant pain treatment.\n* Available information on opioid requirements, expressed as oral morphine milligram equivalents (MME), after infusion start.\n* Sufficient clinical information to document clinical outcomes and adverse events.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Use of lidocaine for an indication other than pain management (procedural sedation or anesthesia).\n* Incomplete clinical information that does not allow assessment of the primary outcome.\n* Surgical, endoscopic or radiological intervention to relieve the obstruction within the first 24 hours after infusion start, when this precludes post-infusion NRS measurement.\n* Documented absolute contraindications to lidocaine that led to early discontinuation of treatment without the possibility of evaluation.","ALL","18 Years",{"count":63,"type":64},50,"ESTIMATED","OBSERVATIONAL","Malignant bowel obstruction is a frequent complication of advanced cancer, particularly of abdominal and pelvic origin, and most affected patients experience pain. Opioids are the mainstay of analgesic treatment, but some patients have pain that does not respond adequately or cannot tolerate further opioid dose increases. Lidocaine infusions are sometimes used as an adjuvant pain treatment in this setting, but specific evidence is limited to case reports and small series.\n\nThis retrospective cohort study will review the medical records of adults with cancer and malignant bowel obstruction who received lidocaine infusions for pain as part of routine palliative care at Hospital Universitario Fundación Santa Fe de Bogotá (Bogotá, Colombia) between 2015 and 2025. The study will describe patient characteristics and lidocaine regimens, and will evaluate changes in pain intensity and opioid requirements before and after the start of the infusion, the proportion of patients with a clinically meaningful pain reduction, adverse events, treatment discontinuation due to toxicity, and hospital outcomes. The investigators will not assign or modify any treatment.",[68,69,70],"Malignant Bowel Obstruction","Cancer Pain","Intestinal Obstruction",[40,72,73],"Palliative Care","Refractory Pain","NOT_YET_RECRUITING","2026-09-28",{"date":77,"type":78},"2026-10-02","ACTUAL",{"date":80,"type":64},"2026-11-01",{"date":82,"type":64},"2027-02-01",{"name":5,"class":6}]