A Phase 3 interventional study of Ketamine and Saline solution in Postoperative Pain and Breast Cancer, sponsored by Institut Bergonié. Completed at 1 site in France. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Institut Bergonié · Phase 3, Interventional, and Treatment
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)
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 230 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
.Kétamine hypersensitivity
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".
Drug: Ketamine
Induction and anesthetic maintenance without ketamine (reference arm / saline solution)
Drug: Saline solution
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
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
| Milestone | Ketamine Arm | Reference Arm |
|---|---|---|
| Started | 115 | 115 |
| Completed | 109 | 104 |
| Not completed | 6 | 11 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Absence of lymph node dissection after intraoperative frozen section of the specimen | 3 | 9 |
Number of participants with at least one consumption of morphine within 48 hours following surgery.
| Participants | Ketamine Arm | Reference Arm |
|---|---|---|
| Morphine Consumption (First 48 Post-operative Hours) | 79 | 77 |
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".
| Participants | Ketamine Arm | Reference Arm |
|---|---|---|
| No pain (VAS < 4) | 106 | 102 |
| Pain (VAS >= 4) | 3 | 2 |
Collected over 6 months after surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine Arm | 0/109 (0%) | 0/109 (0%) | 20/109 (18.3%) |
| Reference Arm | 0/104 (0%) | 0/104 (0%) | 14/104 (13.5%) |
| Event | Ketamine Arm | Reference Arm |
|---|---|---|
| Vomiting NOSGastrointestinal disorders | 12/109 | 12/104 |
| NauseaGastrointestinal disorders | 8/109 | 8/104 |
| Age, Continuous(years) | Ketamine Arm | Reference Arm | Total |
|---|---|---|---|
| Mean | 57.4 ± 12.3 | 58.8 ± 11.4 | 58 ± 12 |
| Sex: Female, Male(Participants) | Ketamine Arm | Reference Arm | Total |
|---|---|---|---|
| Female | 109 | 104 | 213 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Ketamine Arm | Reference Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Ketamine Arm | Reference Arm | Total |
|---|---|---|---|
| France | 109 | 104 | 213 |
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Institut Bergonié