Breast CancerPhase 4NCT01404377
Wound Infiltration and Breast Cancer Surgery
A Phase 4 study testing infiltration with ropivacaine solution in people with Breast Cancer, run by Tenon Hospital, Paris at 1 site in France.
Trial summary
Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- infiltration with ropivacaine solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection
Who cannot join
- Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery
Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection
Read the detailed description
This is a prospective, double-blind, randomized, single centre study Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection are included in the study. Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded.
Patients are allocated randomly into two groups on the morning of surgery, using random numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for induction, and sevoflurane In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane and nitrous oxide for maintenance. Twenty milliliters of the allocated solution are used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. Postoperatively, 8 tablets of paracetamol 500 mg were let at patient' disposal every 24 hours for 3 days. If pain control is not adequate patients receive 5 mg of subcutaneous morphine as a rescue.
Pain intensity is measured on a visual analogue scale graded from 0 to 100. Measurements are performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery. The value of maximum abduction angle is noted.
To evaluate quality of life patients are asked to score on a 4 points scale graded from 0 (the worst) to 3 (the best) the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. A global score is attributed to each patient as the sum of categorical scores. Evaluation is performed at 24, 48 and 72 hour after the end of surgery.
Patients are evaluated at two month for residual pain at rest and on movement using a visual analogue scale and for quality of life as previously defined.
- Conditions
- Breast Cancer
- Being tested
- infiltration with ropivacaine solution
- Keywords
- breast surgery : postoperative pain; ropivacaine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration with ropivacaine solutionProcedure or surgery
Also called naropeine
Patients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Active comparator | treated group (ropivacaine infiltration) Receives: Procedure: infiltration with ropivacaine solution |
| placebo | Placebo comparator | placebo group : infiltration with saline solution Receives: Procedure: infiltration with ropivacaine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% decrease in VAS score on mobilization on the day of surgery
Pain intensity was measured on a VAS graded from 0 to 100, on operated arm at maximum abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery.
Measured: patients will be followed during all the duration of hospital stay and 2 months after surgery
Secondary outcomes (3)
decrease in pain score at rest
Pain intensity was measured on a VAS graded from 0 to 100, at rest at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery.
Measured: duration of hospitalisation and 2 month after surgery
decrease in analgesic rescue consumption
patients received non opioid analgesic (paracetamol) on demand postoperatively
Measured: during hospital stay
improvement in quality of life scoring
Quality of life was scored on a 4 points scale graded from 0 (the worst) to 3 (the best) for the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. Evaluation was performed at 24, 48 and 72 hour after the end of surgery.
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenon Hospital, Paris
- Sponsor type
- University, hospital or other
- Investigators
- Francis Bonnet, MD, Principal investigator, Tenon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404377
- Sponsor's protocol ID
- TenonH
- Other IDs
- bordereau 52 rang 5 N°338
- Status last verified
- May 2011
- First submitted
- 11 Apr 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Vigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23.
PubMed 22114900
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT01404377
- Acronym / sponsor ID
- TenonH
- Conditions
- Breast Cancer
- Keywords
- breast surgery : postoperative pain; ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tenon Hospital, ParisUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection
Detailed description
This is a prospective, double-blind, randomized, single centre study Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection are included in the study. Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality are excluded.
Patients are allocated randomly into two groups on the morning of surgery, using random numbers and sealed envelopes. general anaesthesia using propofol and sufentanil for induction, and sevoflurane In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under general anesthesia with propofol, sufentanil, sevoflurane and nitrous oxide for maintenance. Twenty milliliters of the allocated solution are used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. Postoperatively, 8 tablets of paracetamol 500 mg were let at patient' disposal every 24 hours for 3 days. If pain control is not adequate patients receive 5 mg of subcutaneous morphine as a rescue.
Pain intensity is measured on a visual analogue scale graded from 0 to 100. Measurements are performed at rest and on operated arm abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery. The value of maximum abduction angle is noted.
To evaluate quality of life patients are asked to score on a 4 points scale graded from 0 (the worst) to 3 (the best) the following items: sleep - fatigue - global activity - relationship with relatives - state of mood. A global score is attributed to each patient as the sum of categorical scores. Evaluation is performed at 24, 48 and 72 hour after the end of surgery.
Patients are evaluated at two month for residual pain at rest and on movement using a visual analogue scale and for quality of life as previously defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Active comparator | Procedure: infiltration with ropivacaine solutiontreated group (ropivacaine infiltration) |
| placebo | Placebo comparator | Procedure: infiltration with ropivacaine solutionplacebo group : infiltration with saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult ASA I - II patients, scheduled for unilateral mastectomy or tumorectomy associated with axillary lymph node dissection
Key exclusion criteria (1 listed)
- Patients receiving opioid or any other analgesic treatment for chronic pain before surgery, patients with known allergy to local anaesthetics, and patients with acquired or genetic haemostatic abnormality
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 |
|---|---|---|
| infiltration with ropivacaine solutionAlso: naropeinePatients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision. | Procedure or surgery | placebo, ropivacaine |
Primary outcome
30% decrease in VAS score on mobilization on the day of surgery
Time frame: patients will be followed during all the duration of hospital stay and 2 months after surgery
Pain intensity was measured on a VAS graded from 0 to 100, on operated arm at maximum abduction, at 2, 4, 6, 12, 24, 48, and 72 hour after the end of surgery.
3 secondary outcomes
decrease in pain score at rest
Time frame: duration of hospitalisation and 2 month after surgery
decrease in analgesic rescue consumption
Time frame: during hospital stay
improvement in quality of life scoring
Time frame: during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 22114900Vigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Francis Bonnet, MD principal investigator
Tenon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infiltration with ropivacaine solution in people with Breast Cancer, run by Tenon Hospital, Paris 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 1 inclusion and 1 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 28 Jul 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30% decrease in VAS score on mobilization on the day of surgery (time frame: patients will be followed during all the duration of hospital stay and 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01404377, which also lists 1 linked publication.
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 28 Jul 2011.