Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

Phase 4

• Conditions: Acute Pain; Chronic Pain; Wound Infusion; Mastectomy
• Interventions: Drug: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia); Drug: saline; Drug: Levobupivacaine continuous infusion; Device: intrawound infusion catheter; Drug: morphine; Drug: Patrol

• Registration Number: NCT02035904
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-11
• Study First Submitted QC: 2014-01-11
• Study First Posted: 2014-01-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine	Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)	Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Levobupivacaine	Levobupivacaine continuous infusion	Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Levobupivacaine	intrawound infusion catheter	Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Levobupivacaine	morphine	Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Saline	saline	patient controlled infusion 5 ml bolus, lock out 2 hours
Saline	intrawound infusion catheter	patient controlled infusion 5 ml bolus, lock out 2 hours
Saline	Levobupivacaine continuous infusion	patient controlled infusion 5 ml bolus, lock out 2 hours
Levobupivacaine	Patrol	Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
Saline	morphine	patient controlled infusion 5 ml bolus, lock out 2 hours
Saline	Patrol	patient controlled infusion 5 ml bolus, lock out 2 hours

Primary Outcome Measures

Name	Time	Method
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy	from day 2 to 14

Secondary Outcome Measures

Name	Time	Method
incidence of catheter-related surgical complications	up to 1 month	infections, healing retardation
reduction in pain values at rest and movement in treatment group	14 days
earlier upper limb rehabilitation	up to 1 month	physiatric evaluations
different chronic pain incidence	up to 3 months	phone interview at 1 and 3 months
incidence of drug-related side effects	up to 14 days	local anesthetic toxicity, opioid side effects
earlier return to social activities and good quality of life	up to 1 month	validated SF-36 questionnaire

Trial Locations

Locations (1)

Department of Anesthesia - Pain Therapy Service; 🇮🇹 Pavia, Italy