NCT02035904

Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain
• Chronic Pain
• Wound Infusion
• Mastectomy

Interventions

Type	Name	Description
DRUG	Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)	patient controlled infusion from the 2nd day after surgery
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)

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2014-01-14
• Last updated: 2017-03-03

Locations

1 site across 1 country: Italy