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

NCT02751619 | Completed DMC

• 1 other identifier: 436/2012
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pre-emptive analgesia; Post-thoracotomy pain; Lidocaine patch

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing

  10-score Visual Analogue Scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain

  Post-operative follow-up-points: 6 hours, 12 hours , 24 hours , 36 hours, 48 hours and 72 hours

Secondary Outcomes (5)

• The frequency for hour of activation of PCA Device

  Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.

• Morphine consumption

  Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.

• Flow Expiratory Volume in one second (FEV1%)

  Post-operative follow-up: 72 hours; 96 hours; 120 hours

• Forced Vital Capacity (FVC%)

  Post-operative follow-up: 72 hours; 96 hours; 120 hours

• Laser Evoked Potential Tests.

  Follow-up: 1 month, 3 months, and 6 months after operation

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy

Drug: Lidocaine patch 5%

Placebo Patch

ACTIVE COMPARATOR

A patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy

Drug: Placebo patch

Interventions

Lidocaine patch 5% DRUG

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

Also known as: Lidoderm® (Endo Pharmaceuticals Inc, Malvern, PA, USA)

Lidocaine Group

Placebo patch DRUG

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

Placebo Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years old
• Anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer

You may not qualify if:

• Allergy to Lidocaine
• American Society of Anaesthesiologist (ASA) classification score more than 3
• History of previous thoracic surgical procedures and/or of chronic pain or taking regular analgesics
• Pneumonectomy or concomitant decortication and/or chest wall injury or resection,
• Psychiatric illness
• Participation to other studies

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (5)

• Cerfolio RJ, Bryant AS, Bass CS, Bartolucci AA. A prospective, double-blinded, randomized trial evaluating the use of preemptive analgesia of the skin before thoracotomy. Ann Thorac Surg. 2003 Oct;76(4):1055-8. doi: 10.1016/s0003-4975(03)01023-3.

  PMID: 14529984 BACKGROUND

• Garzon-Rodriguez C, Casals Merchan M, Calsina-Berna A, Lopez-Romboli E, Porta-Sales J. Lidocaine 5 % patches as an effective short-term co-analgesic in cancer pain. Preliminary results. Support Care Cancer. 2013 Nov;21(11):3153-8. doi: 10.1007/s00520-013-1948-7. Epub 2013 Sep 3.

  PMID: 24000041 BACKGROUND

• Vrooman B, Kapural L, Sarwar S, Mascha EJ, Mihaljevic T, Gillinov M, Qavi S, Sessler DI. Lidocaine 5% Patch for Treatment of Acute Pain After Robotic Cardiac Surgery and Prevention of Persistent Incisional Pain: A Randomized, Placebo-Controlled, Double-Blind Trial. Pain Med. 2015 Aug;16(8):1610-21. doi: 10.1111/pme.12721. Epub 2015 Jul 14.

  PMID: 26176878 BACKGROUND

• Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.

  PMID: 19448228 BACKGROUND

• Cheng YJ. Lidocaine Skin Patch (Lidopat(R) 5%) Is Effective in the Treatment of Traumatic Rib Fractures: A Prospective Double-Blinded and Vehicle-Controlled Study. Med Princ Pract. 2016;25(1):36-9. doi: 10.1159/000441002. Epub 2015 Nov 6.

  PMID: 26539836 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidoderm

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mario Santini, MD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 26, 2016
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share