Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
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| ClinicalTrials.gov Identifier: NCT02035904 |
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Recruitment Status : Unknown
Verified March 2017 by Massimo Allegri, IRCCS Policlinico S. Matteo.
Recruitment status was: Recruiting
First Posted : January 14, 2014
Last Update Posted : March 3, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Pain Chronic Pain Wound Infusion Mastectomy | Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia) Drug: saline Drug: Levobupivacaine continuous infusion Device: intrawound infusion catheter Drug: morphine Drug: Patrol | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | January 2013 |
| Estimated Primary Completion Date : | September 2017 |
| Estimated Study Completion Date : | December 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
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Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
patient controlled infusion from the 2nd day after surgery Drug: Levobupivacaine continuous infusion Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients Device: intrawound infusion catheter placed by surgeon at the end surgery in all patients Drug: morphine 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 Drug: Patrol tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal) |
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Placebo Comparator: Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
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Drug: saline
patient controlled infusion from the 2nd day after surgery Drug: Levobupivacaine continuous infusion Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients Device: intrawound infusion catheter placed by surgeon at the end surgery in all patients Drug: morphine 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 Drug: Patrol tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal) |
- reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy [ Time Frame: from day 2 to 14 ]
- 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 ]local anesthetic toxicity, opioid side effects
- incidence of catheter-related surgical complications [ Time Frame: up to 1 month ]infections, healing retardation
- earlier upper limb rehabilitation [ Time Frame: up to 1 month ]physiatric evaluations
- earlier return to social activities and good quality of life [ Time Frame: up to 1 month ]validated SF-36 questionnaire
- different chronic pain incidence [ Time Frame: up to 3 months ]phone interview at 1 and 3 months
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035904
| Contact: Allegri Massimo, MD | +390382502627 | massimo.allegri@unipv.it |
| Italy | |
| Department of Anesthesia - Pain Therapy Service | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: Allegri Massimo, MD +390382502627 massimo.allegri@unipv.it | |
| Sub-Investigator: Bugada Dario, MD | |
| Principal Investigator: | Allegri Massimo, MD | Pain Therapy Service IRCCS Policlinico S Matteo Pavia Italy |
| Responsible Party: | Massimo Allegri, MD, IRCCS Policlinico S. Matteo |
| ClinicalTrials.gov Identifier: | NCT02035904 |
| Other Study ID Numbers: |
2011-006331-35 |
| First Posted: | January 14, 2014 Key Record Dates |
| Last Update Posted: | March 3, 2017 |
| Last Verified: | March 2017 |
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Chronic Pain Acute Pain Pain Neurologic Manifestations Morphine Levobupivacaine Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local Anesthetics |