Postoperative PainPhase 3KETAMINENCT00210210
Administration of Ketamine to Prevent the Post-operative Pain
A Phase 3 study testing Ketamine and Saline solution in people with Postoperative Pain and Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Cancer
- What is being tested?
- Ketamine and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2004to 31 Dec 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years older
- ASA class 1 or 2
- with surgery of breast cancer (mastectomy or tumorectomy)
Who cannot join
- .Kétamine hypersensitivity
- Major psychiatric disorders
- Major cardio-vascular disorders
- Major neurologic disorders
- Major ocular disorders
- Morphine in pre-operative period
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
About this study
Official title: Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology
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)
- Conditions
- Postoperative Pain, Breast Cancer
- Being tested
- Ketamine, Saline solution
- Keywords
- Post-operative-pain, Breast cancer, Morphine, Analgesia
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Saline solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Arm | Experimental | 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". Receives: Drug: Ketamine |
| Reference Arm | Sham comparator | Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption (First 48 Post-operative Hours)
Number of participants with at least one consumption of morphine within 48 hours following surgery.
Measured: within 48 hours following surgery
Secondary outcomes (1)
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".
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start31 Jan 2004
- Primary completion31 Jul 2005
- Study completion31 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie COLOMBANI, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210210
- Sponsor's protocol ID
- IB2004-04
- Other IDs
- KETAMINE
- Acronym
- KETAMINE
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2005
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology
- ClinicalTrials.gov ID
- NCT00210210
- Acronym / sponsor ID
- KETAMINE / IB2004-04
- Conditions
- Postoperative Pain, Breast Cancer
- Keywords
- Post-operative-pain, Breast cancer, Morphine, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 31 Jan 2004 (actual)
- Primary completion
- 31 Jul 2005 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 8 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Arm | Experimental | Drug: KetamineAnesthetic 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". |
| Reference Arm | Sham comparator | Drug: Saline solutionInduction and anesthetic maintenance without ketamine (reference arm / saline solution) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years older
- ASA class 1 or 2
- with surgery of breast cancer (mastectomy or tumorectomy)
Key exclusion criteria (6 listed)
- .Kétamine hypersensitivity
- Major psychiatric disorders
- Major cardio-vascular disorders
- Major neurologic disorders
- Major ocular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine | Drug | Ketamine Arm |
| Saline solution | Drug | Reference Arm |
Primary outcome
Morphine Consumption (First 48 Post-operative Hours)
Time frame: within 48 hours following surgery
Number of participants with at least one consumption of morphine within 48 hours following surgery.
1 secondary outcome
Post-operative Pain
Time frame: 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie COLOMBANI, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine and Saline solution in people with Postoperative Pain and Breast Cancer, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption (First 48 Post-operative Hours) (time frame: within 48 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.