Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Santa Fe de Bogota
About this trial
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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older with a diagnosis of cancer.
Diagnosis of malignant bowel obstruction confirmed by clinical criteria and/or imaging studies and documented in the medical record.
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.
Receipt of a lidocaine infusion with analgesic intent as adjuvant pain treatment.
Disqualifiers
Age under 18 years.
Use of lidocaine for an indication other than pain management (procedural sedation or anesthesia).
Incomplete clinical information that does not allow assessment of the primary outcome.
Surgical, endoscopic or radiological intervention to relieve the obstruction within the first 24 hours after infusion start, when this precludes post-infusion NRS measurement.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Lidocaine
DrugContinuous 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Lidocaine Infusion Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (within 24 hours before infusion start), 24 hours and 48 hours after infusion startSecondary outcomes
1
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.
Time frame
24 to 48 hours after infusion start2
Change in Opioid Requirements in Oral Morphine Milligram Equivalents per 24 Hours (MME/24 h)
Total daily opioid dose converted to oral morphine milligram equivalents (MME/24 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.
Time frame
Baseline (within 24 hours before infusion start), 24 hours and 48 hours after infusion start3
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.
Time frame
From infusion start until the end of the infusionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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