Intrathecal Administration of the Drug, Intrathecal Analgesic, Pancreatic Cancer Pain, Pancreatic Carcinoma
Conditions
Brief 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
DEVICEIntrathecal catheter connected to an implantable pump
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.
DRUGAdministration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections
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.
Sponsors
Clinique Bizet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edmonton Symptom Assessment System (ESAS) Overall Quality of Life Score | 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 | 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) | 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) | 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 | 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) | 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 | 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) | 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 |
Countries
France
Contacts
CONTACTBouchra BENKESSOU Chef de projet Recherche Clinique
Outcome results
None listed