Pain After MastectomyPhase 2ROPINCT01855529
ROPI Study : Ropivacaine Interest in Postsurgical Pain After Mastectomy
A Phase 2 study of Pain After Mastectomy, run by Centre Jean Perrin at 1 site in France.
Trial summary
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain After Mastectomy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Aug 2016
- Phase
- Phase 2
- 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
- Age> 18 years
- ASA I-II, WHO 0-1
- mastectomy alone, mastectomy + GGS + mastectomy CA
- No previous history of chronic pain requiring regular intake of analgesics or long-term
- Failure to take opioids within 30 days before surgery
Who cannot join
- Long-term treatment analgesic or taking opioids within 30 days before surgery
- Concurrent treatment with a drug test, participation in another therapeutic clinical trial within <30 days
- proven allergy to local anesthetics of the amide
- Skin Inflammation
- Sepsis local
- Kidney failure, liver failure, severe or poorly controlled diabetes
- Inability to respond to the assessment of pain using a visual analogue scale (VAS) or a numerical scale (FR).
- mastectomy with immediate breast reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.
Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.
Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.
- Conditions
- Pain After Mastectomy
- Being tested
- Ropivacaine in one arm and placebo (NaCl) in the other arm
- Keywords
- ropivacaine, pain, mastectomy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine in one arm and placebo (NaCl) in the other armDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine arm | Experimental | Ropivacaïne 2 mg/ml 10ml/h Receives: Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm |
| NaCl arm | Placebo comparator | NaCl 0,9% 250ml 10 ml/h Receives: Drug: Ropivacaine in one arm and placebo (NaCl) in the other arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily consumption of morphine during the first 48 postoperative hours.
Measured: during the first 48 postoperative hours
Secondary outcomes (9)
Determination of Ropivacaine plasma (analytical blank: T0)
Measured: T0, the day of surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The intensity of pain, VAS or EN
Measured: During the first 48 h after surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The site of pain
Measured: during the first 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: A potential analgesics administered
Measured: during the first 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Constant: pulse, blood pressure, tympanic temperature, respiratory rate, sedation (0: awake, 1: sleepy, 2 comatose).
Measured: during 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects The most common expected morphine: nausea, vomiting, pruritus, acute urine retention.
Measured: during the 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects of ropivacaine expected the most common: nausea, vomiting, headache, dizziness, paresthesias.
Measured: during 48 hours after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Condition of dressing • On any abnormality at the site of administration: local redness, pain, skin warmth, pruritus.
Measured: during the 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Determination of Ropivacaine plasma at T0+ 24 h, T0+48h
Measured: during 48h after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After MastectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855529
- Sponsor's protocol ID
- 2012-000227-40
- Acronym
- ROPI
- Status last verified
- Sep 2016
- First submitted
- 14 May 2013
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.
- ClinicalTrials.gov ID
- NCT01855529
- Acronym / sponsor ID
- ROPI / 2012-000227-40
- Conditions
- Pain After Mastectomy
- Keywords
- ropivacaine, pain, mastectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 May 2013 (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.
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.
Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.
Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine arm | Experimental | Drug: Ropivacaine in one arm and placebo (NaCl) in the other armRopivacaïne 2 mg/ml 10ml/h |
| NaCl arm | Placebo comparator | Drug: Ropivacaine in one arm and placebo (NaCl) in the other armNaCl 0,9% 250ml 10 ml/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age> 18 years
- ASA I-II, WHO 0-1
- mastectomy alone, mastectomy + GGS + mastectomy CA
- No previous history of chronic pain requiring regular intake of analgesics or long-term
- Failure to take opioids within 30 days before surgery
Key exclusion criteria (8 listed)
- Long-term treatment analgesic or taking opioids within 30 days before surgery
- Concurrent treatment with a drug test, participation in another therapeutic clinical trial within <30 days
- proven allergy to local anesthetics of the amide
- Skin Inflammation
- Sepsis local
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 |
|---|---|---|
| Ropivacaine in one arm and placebo (NaCl) in the other arm | Drug | NaCl arm, Ropivacaine arm |
Primary outcome
Daily consumption of morphine during the first 48 postoperative hours.
Time frame: during the first 48 postoperative hours
9 secondary outcomes
Determination of Ropivacaine plasma (analytical blank: T0)
Time frame: T0, the day of surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The intensity of pain, VAS or EN
Time frame: During the first 48 h after surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: • The site of pain
Time frame: during the first 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: A potential analgesics administered
Time frame: during the first 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Constant: pulse, blood pressure, tympanic temperature, respiratory rate, sedation (0: awake, 1: sleepy, 2 comatose).
Time frame: during 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects The most common expected morphine: nausea, vomiting, pruritus, acute urine retention.
Time frame: during the 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Possible side effects of ropivacaine expected the most common: nausea, vomiting, headache, dizziness, paresthesias.
Time frame: during 48 hours after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Condition of dressing • On any abnormality at the site of administration: local redness, pain, skin warmth, pruritus.
Time frame: during the 48h after the surgery
Assessment every 4 hours by the IDE that will support the patient during the first 48 hours, then every analgesic taken: Determination of Ropivacaine plasma at T0+ 24 h, T0+48h
Time frame: during 48h after the surgery
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 12 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Pain After Mastectomy, run by Centre Jean Perrin 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 5 inclusion and 8 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 12 Sep 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Daily consumption of morphine during the first 48 postoperative hours. (time frame: during the first 48 postoperative hours). 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 12 Sep 2017.