Chronic Pain
Conditions
Keywords
Current opioid treatment, Nitrous oxide, Chronic pain, Opioid therapy, Postoperative hyperalgesia, Acute opioid tolerance
Brief summary
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.
Interventions
PROCEDUREAir
Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.
PROCEDUREProtox
Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Sponsors
Institut Bergonié
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Older than 18 years * Current opioid treatment \> 1 month * patients scheduled to undergo vertebroplasty with general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Morphine Consumption | Between surgery and up to 48 hours | Morphine consumption (mg) during PCA (Patient Controlled Analgesia) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Post-operative Pain | Between surgery and up to 48 hours | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 18 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Protox Arm (Experimental) | Total | Air Arm (Reference) |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 2.7 | 62.6 years STANDARD_DEVIATION 2.5 | 61.6 years STANDARD_DEVIATION 2.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 18 participants | 37 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Post-operative Morphine Consumption
Morphine consumption (mg) during PCA (Patient Controlled Analgesia)
Time frame: Between surgery and up to 48 hours
Population: Participants with a record of morphine consumption (mg) during PCA (Patient Controlled Analgesia)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Air Arm (Reference) | Post-operative Morphine Consumption | 54.6 mg | Standard Deviation 51.2 |
| Protox Arm (Experimental) | Post-operative Morphine Consumption | 44.8 mg | Standard Deviation 46.4 |
Comparison: T-test for a difference of means, assuming independant samples and unequal variancesp-value: 0.595% CI: [-23.4, 42.8]t-test, 2 sided
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.
Time frame: Between surgery and up to 48 hours
Population: Participants with a VAS score record available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Air Arm (Reference) | Proportion of Participants With Post-operative Pain | 2 Participants |
| Protox Arm (Experimental) | Proportion of Participants With Post-operative Pain | 1 Participants |