Status
Not yet recruiting
Phase
Not applicable
Enrollment
40
Locations
3
Results
Not posted
Publications
9
Study summary
The aim of this clinical trial is to assess the effectiveness of intratracheal analgesia on pain intensity in cancer patients, from the start of treatment up to 3 months. It will also investigate the safety of this technique. The main questions it seeks to answer are as follows: What is the impact on the use of opioid analgesics, and can this be measured? What is the quality of life? What is the quality of sleep, and can this be assessed? How does the patient's weight change? Is the patient satisfied? What is the patient's overall survival? The researchers will assess the equivalent daily dose of morphine (mg/day) between enrolment and follow-up visits, as well as the number of patients requiring an escalation of analgesic treatment. Overall quality of life score measured using the ESAS questionnaire between enrolment and follow-up visits; satisfaction assessed using a numerical satisfaction scale (0-10); sleep quality assessed using the ISI questionnaire; and the tolerability and safety of the technique assessed by monitoring adverse events. Eligible participants: Following implantation of the intrathecal pump, participants will have scheduled consultations at day 30, then at 3, 6, 9 and 12 months, with questionnaires to be completed.
Interventions
DEVICE
Epidural puncture (AL injection), followed by a lumbar puncture and collection of cerebrospinal fluid. Positioning of the catheter behind the spinal cord at the desired metameric level for the pancreas (T5-T7), and positioning of the pump in the flank or buttock.
DRUG
Medications are administered via an intrathecal catheter connected to an implantable pump or via periodic injections; the patient is admitted to hospital with morphine (IV, PO, transdermal) discontinued on entry to the unit (the same applies to methadone). Depending on the condition of the patient's abdominal skin (stoma, multiple injections, etc.) and any foreseeable technical difficulties during MRI scanning (in the left or right lateral positions), the procedure is performed under fluoroscopy, with appropriate antibiotic prophylaxis, under local anaesthesia, epidural anaesthesia and light sedation. Product used, dosage and frequency: Opioids: μ and δ receptors: Morphine sulphate: 50 mg/ml Ca++ channels: ziconotide: initial dose 0.5 µg/day Sodium channels: 1% ropivacaine As with a patient-controlled analgesia (PCA) system: Continuous infusion + bolus or sequential boluses Patient education on the use of the pump during their hospital stay.
Timeline
First posted
Jul 29, 2026
Study start
Jun 2026
Primary completion
Mar 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 31, 2026
Outcomes
Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in pain intensity score measured by the ESAS subscale from baseline to follow-up visits. Unit of Measure: Score on a scale (0 to 10) Scale Range (Minimum and Maximum Values): 0 to 10 Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).
Change in Edmonton Symptom Assessment System (ESAS) Overall Quality of Life Score
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in overall score as measured by the Edmonton Symptom Assessment System (ESAS) from baseline to follow-up visits. Unit of Measure: Score on a scale (ESAS Score) Scale Range (Minimum and Maximum Values): 0 to 10 Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).
Proportion of Patients Requiring Pain Treatment Escalation
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Number of patients requiring an increase or escalation in pain management treatment during follow-up. Unit of Measure: Number of participants (or Percentage)
Change in Daily Morphine Equivalent Dose (MED)
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in daily opioid dose from baseline to follow-up visits. Unit of Measure: mg/day
Change in Sleep Quality Score Insomnia Severity Index (ISI)
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in insomnia severity measured by the Insomnia Severity Index (ISI) questionnaire from baseline to follow-up visits. Scale Range (Minimum and Maximum Values): 0 to 28 (Derived from summing the 7 individual items, each scored on a 0 to 4 scale evaluating sleep onset, maintenance, early morning awakening, satisfaction, daytime interference, noticeability, and distress) Direction of Scores: Higher score 4 means a worse outcome (greater insomnia severity and impaired quality of life) Unit of Measure: Score on a scale (ISI Score)
Change in Body Weight
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Change in body weight from baseline to follow-up visits. Unit of Measure: Kilograms (kg)
Patient Satisfaction Clinical Global Impressions Scale (typically either CGI-Severity or CGI-Improvement)
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Overall patient satisfaction Clinical Global Impressions (typically either CGI-Severity or CGI-Improvement) rated on a numerical scale. Unit of Measure: Score on a scale Scale Range (Minimum and Maximum Values): 1 to 7 Direction of Scores: Higher scores mean a worse outcome (e.g., greater illness severity or worsening condition).
Incidence of Adverse Events Related to Intratracheal Analgesia
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Number of participants experiencing at least one adverse event related to the intratracheal analgesia technique. Unit of Measure: Number of participants
Incidence of Serious Adverse Events (SAEs)
Time frame · Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Number of participants experiencing a serious adverse event during the study period. Unit of Measure: Number of participants
Eligibility
Inclusion Criteria: Subject aged over 20 years * Patient with histologically confirmed pancreatic carcinoma * Chronic cancer-related pain that is inadequately controlled by standard treatment or for whom analgesics are contraindicated. * EMO \< 120 mg/day Patients experiencing side effects: sedation, vomiting, constipation, or an allergy to morphine. * Signed informed consent * Participants affiliated with or eligible for a social security scheme * Agree to complete the various study questionnaires Exclusion Criteria: Patients under the age of 20. * Contraindications to intratracheal analgesia * Acute respiratory infection * Uncontrolled coagulation disorder * Pregnancy or breastfeeding * Unable to comply with medical follow-up for the study. * Adults who are legally protected, under guardianship or under a conservatorship
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
Benkessou
Paris, France
Bizet Clinic
Paris, France
Clinique Bizet
Paris, France
Publications
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