Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

Summary

RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

Conditions

• Metastatic Cancer
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

Acetaminophen

Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).

DRUG

Morphine Sulfate

Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.

OTHER

Questionnaire administration

Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on : * The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital, * the background morphine analgesic treatment during the last 24 hours, * the morphine analgesic treatment taken during painful attacks, * the possible undesirable effects of morphine treatment. * the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent

PROCEDURE

Quality-of-life assessment

Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.

PROCEDURE

Radiofrequency ablation

Recent technique of thermal destruction of tumors. This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser). Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

Sponsors & Collaborators

• Institut Bergonié

  lead OTHER

Principal Investigators

• Florence Dixmerias, MD · Institut Bergonié

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-24

Primary Completion

2016-02-11

Completion

2016-03-16

Countries

• France

Study Locations