MedTrace Logo

Preventive Skin Analgesia With Lidocaine Patch 5% for Controlling Post-thoracotomy Pain

NCT02751619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-04-26

No results posted yet for this study

Summary

Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative pulmonary infections. Thus, an effective analgesia is crucial in order to reduce perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy pain.

Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard strategies for thoracic surgery but the difficult of performing them in all patients and their potential complications are all factors that limit their use. Systemic administration of opioids is the simplest and common strategy to provide analgesia but it may be associated with several undesirable effects, such as respiratory depression, sedation, nausea, constipation and vomiting.

In the recent years, preventive analgesia is become one of the most promising strategy of postoperative pain control. It is based on the concept of administering analgesic drugs before the occurrence of nociceptive input in order to prevent central sensitization. The efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on controlling pain after thoracic procedure.

Pain following thoracotomy has a multifactorial genesis including surgical incision, intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations could be more effective than a single strategy targeting one site along the pain pathway.

Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of systemic morphine analgesia for controlling post-operative pain following thoracotomy.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Lidocaine patch 5%

Lidocaine patch 5% was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy

DRUG

Placebo patch

A patch without lidocaine was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Mario Santini, MD · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-05-31
Completion
2015-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751619 on ClinicalTrials.gov