Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction

NCT07856251 | Not Yet Recruiting

• 1 other identifier: CCEI-19342-2026
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malignant Bowel Obstruction; Cancer Pain; Intestinal Obstruction

Keywords

Lidocaine; Palliative Care; Refractory Pain

Outcome Measures

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.

  Baseline (within 24 hours before infusion start), 24 hours and 48 hours after infusion start

Secondary Outcomes (3)

• Percentage of Patients With a Clinically Meaningful Analgesic Response

  24 to 48 hours after infusion start

• Change in Opioid Requirements in Oral Morphine Milligram Equivalents per 24 Hours (MME/24 h)

  Baseline (within 24 hours before infusion start), 24 hours and 48 hours after infusion start

• Number of Patients With Adverse Events Attributed to Lidocaine

  From infusion start until the end of the infusion

Study Arms (1)

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.

Drug: Lidocaine

Interventions

Lidocaine DRUG

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.

Lidocaine Infusion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Available information on opioid requirements, expressed as oral morphine milligram equivalents (MME), after infusion start.
• Sufficient clinical information to document clinical outcomes and adverse events.

You may not qualify if:

• 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.
• Documented absolute contraindications to lidocaine that led to early discontinuation of treatment without the possibility of evaluation.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

MeSH Terms

Conditions

Cancer Pain; Intestinal Obstruction; Pain, Intractable

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Juan Guillermo Santacruz Escudero, MD, Internist, Palliative care

CONTACT

+57 601 6030303; juan.santacruz@fsfb.org.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Internist, Pain and Palliative Care Specialist

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share