Breast Cancer, Postoperative Pain
Conditions
Keywords
Post-operative-pain, Breast cancer, Morphine, Analgesia
Brief summary
The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)
Interventions
DRUGKetamine
DRUGSaline solution
Sponsors
Institut Bergonié
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 years older * ASA class 1 or 2 * with surgery of breast cancer (mastectomy or tumorectomy)
Exclusion criteria
.Kétamine hypersensitivity * Major psychiatric disorders * Major cardio-vascular disorders * Major neurologic disorders * Major ocular disorders * Morphine in pre-operative period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption (First 48 Post-operative Hours) | within 48 hours following surgery | Number of participants with at least one consumption of morphine within 48 hours following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | 48 hours after surgery | Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain). A VAS score \>= 4 wwas considered as Pain. A VAS sore \<4 was considered as No pain. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Arm Anesthetic induction: Ketamine at 0.15 mg/kg is added to the Reference protocol.
Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the Reference protocol.
Ketamine | 109 |
| Reference Arm Induction and anesthetic maintenance without ketamine (reference arm / saline solution)
Saline solution | 104 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | absence of lymph node dissection after intraoperative frozen section of the specimen | 3 | 9 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Ketamine Arm | Reference Arm | Total |
|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 12.3 | 58.8 years STANDARD_DEVIATION 11.4 | 58 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment France | 109 participants | 104 participants | 213 participants |
| Sex: Female, Male Female | 109 Participants | 104 Participants | 213 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 104 |
| other Total, other adverse events | 20 / 109 | 14 / 104 |
| serious Total, serious adverse events | 0 / 109 | 0 / 104 |
Outcome results
Primary
Morphine Consumption (First 48 Post-operative Hours)
Number of participants with at least one consumption of morphine within 48 hours following surgery.
Time frame: within 48 hours following surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine Arm | Morphine Consumption (First 48 Post-operative Hours) | 79 Participants |
| Reference Arm | Morphine Consumption (First 48 Post-operative Hours) | 77 Participants |
Secondary
Post-operative Pain
Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain). A VAS score \>= 4 wwas considered as Pain. A VAS sore \<4 was considered as No pain.
Time frame: 48 hours after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Arm | Post-operative Pain | Pain (VAS >= 4) | 3 Participants |
| Ketamine Arm | Post-operative Pain | No pain (VAS < 4) | 106 Participants |
| Reference Arm | Post-operative Pain | No pain (VAS < 4) | 102 Participants |
| Reference Arm | Post-operative Pain | Pain (VAS >= 4) | 2 Participants |