Acute PainPhase 4NCT02035904
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
A Phase 4 study testing saline, Levobupivacaine continuous infusion and intrawound infusion catheter in people with Acute Pain and Chronic Pain, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Acute Pain, Chronic Pain, Wound Infusion
- What is being tested?
- saline, Levobupivacaine continuous infusion and intrawound infusion catheter
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Dec 2017
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- F; age 18 to 70
- American Society of Anesthesiologists (ASA) I e II;
- breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;
- immediate sub-pectoral prosthetic reconstruction;
- signed informed consent.
Who cannot join
- preexisting pectoral, axillar, thoracic homolateral pain
- habitual opioid consumption;
- drug-alcoholics addiction ;
- ICU postoperative recovery;
- kidney failure (creatinin > 2 g/dl, creatinin <clearance 30 ml/h) and/or hepatic failure (cholinesterase < 2000 UI);
- cardiac arrhythmias o;
Show all 12Show fewer
- Epilepsy;
- Psychiatric, cognitive disorders, mental retardation;
- Coagulopathies (INR > 2, activated partial thromboplastin time - aPTT>44 sec);
- platelet count less than 100.000/mm3;
- BMI > 30;
- Allergies to study drugs.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Anesthesia - Pain Therapy Service
Pavia, Pavia, 27100
Allegri Massimo, MD, +390382502627, massimo.allegri@unipv.it
Bugada Dario, MD
About this study
The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. The study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. Intralesional catheter is placed at the end of surgery. In the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4. From the second postoperative day morphine PCA is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use.
Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. Patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3 month is performed to investigate pain chronicization.
Read more
Surgical evaluation is provided, also to establish any catheter-related infective or healing complication.
Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process.
A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.
- Conditions
- Acute Pain, Chronic Pain, Wound Infusion, Mastectomy
- Being tested
- Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia), saline, Levobupivacaine continuous infusion, intrawound infusion catheter, morphine
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)Drug
patient controlled infusion from the 2nd day after surgery
salineDrug
patient controlled infusion from the 2nd day after surgery
Levobupivacaine continuous infusionDrug
Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
intrawound infusion catheterDevice
placed by surgeon at the end surgery in all patients
morphineDrug
PCA with morphine: 0,5 mg/ml bolus 1 mg lock-out 5 min max 20 mg in 4 hs - for the first 24 hs as rescue analgesia
PatrolDrug
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Experimental | Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours Receives: Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia); Drug: Levobupivacaine continuous infusion; Device: intrawound infusion catheter; Drug: morphine; Drug: Patrol |
| Saline | Placebo comparator | patient controlled infusion 5 ml bolus, lock out 2 hours Receives: Drug: saline; Drug: Levobupivacaine continuous infusion; Device: intrawound infusion catheter; Drug: morphine; Drug: Patrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
Measured: from day 2 to 14
Secondary outcomes (6)
reduction in pain values at rest and movement in treatment group
Measured: 14 days
incidence of drug-related side effects
local anesthetic toxicity, opioid side effects
Measured: up to 14 days
incidence of catheter-related surgical complications
infections, healing retardation
Measured: up to 1 month
earlier upper limb rehabilitation
physiatric evaluations
Measured: up to 1 month
earlier return to social activities and good quality of life
validated SF-36 questionnaire
Measured: up to 1 month
different chronic pain incidence
phone interview at 1 and 3 months
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Allegri, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Allegri Massimo, MD, Principal investigator, Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035904
- Sponsor's protocol ID
- 2011-006331-35
- Status last verified
- Mar 2017
- First submitted
- 11 Jan 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
- ClinicalTrials.gov ID
- NCT02035904
- Acronym / sponsor ID
- 2011-006331-35
- Conditions
- Acute Pain, Chronic Pain, Wound Infusion, Mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jan 2014 (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.
The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. The study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. Intralesional catheter is placed at the end of surgery. In the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4. From the second postoperative day morphine PCA is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use.
Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. Patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3 month is performed to investigate pain chronicization.
Surgical evaluation is provided, also to establish any catheter-related infective or healing complication.
Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process.
A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Experimental | Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia), Drug: Levobupivacaine continuous infusion, Device: intrawound infusion catheter, Drug: morphine, Drug: PatrolLevobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours |
| Saline | Placebo comparator | Drug: saline, Drug: Levobupivacaine continuous infusion, Device: intrawound infusion catheter, Drug: morphine, Drug: Patrolpatient controlled infusion 5 ml bolus, lock out 2 hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- F; age 18 to 70
- American Society of Anesthesiologists (ASA) I e II;
- breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;
- immediate sub-pectoral prosthetic reconstruction;
- signed informed consent.
Key exclusion criteria (12 listed)
- preexisting pectoral, axillar, thoracic homolateral pain
- habitual opioid consumption;
- drug-alcoholics addiction ;
- ICU postoperative recovery;
- kidney failure (creatinin > 2 g/dl, creatinin <clearance 30 ml/h) and/or hepatic failure (cholinesterase < 2000 UI);
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 |
|---|---|---|
| Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)patient controlled infusion from the 2nd day after surgery | Drug | Levobupivacaine |
| salinepatient controlled infusion from the 2nd day after surgery | Drug | Saline |
| Levobupivacaine continuous infusionContinuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients | Drug | Levobupivacaine, Saline |
| intrawound infusion catheterplaced by surgeon at the end surgery in all patients | Device | Levobupivacaine, Saline |
| morphinePCA with morphine: 0,5 mg/ml bolus 1 mg lock-out 5 min max 20 mg in 4 hs - for the first 24 hs as rescue analgesia | Drug | Levobupivacaine, Saline |
| Patroltramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal) | Drug | Levobupivacaine, Saline |
Primary outcome
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
Time frame: from day 2 to 14
6 secondary outcomes
reduction in pain values at rest and movement in treatment group
Time frame: 14 days
incidence of drug-related side effects
Time frame: up to 14 days
incidence of catheter-related surgical complications
Time frame: up to 1 month
earlier upper limb rehabilitation
Time frame: up to 1 month
earlier return to social activities and good quality of life
Time frame: up to 1 month
different chronic pain incidence
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Allegri Massimo, MD principal investigator
Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy
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 saline, Levobupivacaine continuous infusion and intrawound infusion catheter in people with Acute Pain and Chronic Pain, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 12 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: status not confirmed, as of the sponsor's last update on 3 Mar 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allegri Massimo, MD (+390382502627, massimo.allegri@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy (time frame: from day 2 to 14). 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 3 Mar 2017.