Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

Chronic Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02035904
• Other study ID #: 2011-006331-35
• Status: Recruiting
• Phase: Phase 4
• First received: January 11, 2014
• Last updated: March 1, 2017
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: IRCCS Policlinico S. Matteo
• Contact: Allegri Massimo, MD
• Phone: +390382502627
• Email: massimo.allegri[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Mastectomy
• Wound Infusion

Intervention

Drug:
• Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)
patient controlled infusion from the 2nd day after surgery
• saline
patient controlled infusion from the 2nd day after surgery
• 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
• Patrol
tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)

Locations

Country	Name	City	State
Italy	Department of Anesthesia - Pain Therapy Service	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy		from day 2 to 14
Secondary	reduction in pain values at rest and movement in treatment group		14 days
Secondary	incidence of drug-related side effects	local anesthetic toxicity, opioid side effects	up to 14 days
Secondary	incidence of catheter-related surgical complications	infections, healing retardation	up to 1 month
Secondary	earlier upper limb rehabilitation	physiatric evaluations	up to 1 month
Secondary	earlier return to social activities and good quality of life	validated SF-36 questionnaire	up to 1 month
Secondary	different chronic pain incidence	phone interview at 1 and 3 months	up to 3 months

External Links

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