Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air arm (Reference) | Sham Comparator | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. |
|
| Protox Arm (Experimental) | Experimental | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air | Procedure | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Morphine Consumption | Morphine consumption (mg) during PCA (Patient Controlled Analgesia) | Between surgery and up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Post-operative Pain | Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have pain if VAS score is >= 40. | Between surgery and up to 48 hours |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabrice Lakdja, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Air Arm (Reference) | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. |
| FG001 | Protox Arm (Experimental) | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Air Arm (Reference) | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Morphine Consumption | Morphine consumption (mg) during PCA (Patient Controlled Analgesia) | Participants with a record of morphine consumption (mg) during PCA (Patient Controlled Analgesia) | Posted | Mean | Standard Deviation | mg | Between surgery and up to 48 hours |
|
48 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Arm (Reference) | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000388 | Air |
| D050768 | Protoporphyrinogen Oxidase |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Protox | Procedure | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. |
|
| BG001 |
| Protox Arm (Experimental) |
Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
|
|
|
| Secondary | Proportion of Participants With Post-operative Pain | Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have pain if VAS score is >= 40. | Participants with a VAS score record available. | Posted | Count of Participants | Participants | Between surgery and up to 48 hours |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Protox Arm (Experimental) | Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D044925 | Oxidoreductases Acting on CH-CH Group Donors |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |