Clinical trial to assess diaphragm´s function after local anaesthetic infiltration compared to placebo in order to avoid post-surgery pain in patients undergoing thoracic surgery.

Conditions: Ipsilateral shoulder pain after thoracotomy for lung resection.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-005062-30-ES

Lead Sponsor: niversity Hospital Germans Trias i Pujol

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-18-85 years old patients undergoing lung resection surgery using postero-lateral thoracotomy.

-Signed Informed consent of this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Inability or contraindication to perform epidural analgesia.
-Epidural analgesia malfunction intra or post-surgery
-Neuromuscular diseases, previous shoulder pain or chronic analgesic use
-Lidocaine allergy
-Vertebral fractures and/or high spinal cord injuries (C4 or above)
-Previous diaphragm paralysis of the hemithorax undergoing surgical procedure
-Inflammatory polyradiculoneuropathies or other neuromuscular diseases.
-Patients with pacemaker
-Morbid obesity (BMI>40)
-Incapacity to understand analogical visual and or verbal pain scales
-Extended lung resection including chest wall and/or vertebral bodies
-Pregnancy or lactation
-Patient refusal to participate

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses, using phrenic nerve electroneurografy, if the periphrenic fat pad infiltration with 10cc 2% lidocaine during lung resection surgery produces a functional alteration of the phrenic nerve and therefore an alteration of the ipsilateral hemidiaphragm motility.;Secondary Objective: 1- To compare the clinical and spirometric alteration degree produced by the periphrenic fat pad infiltration with 10 cc of 2% lidocaine vs placebo in patients undergoing lung surgery.<br><br>2- To compare pain intensity in both groups;Primary end point(s): Safety end point: median change of latency (ms) and amplitude (mV) of the registered CMAP (Compound muscle action potential) between basal measure and the one measured after surgery (4-6 hours) in both groups. (Basal measure: intraoperative just before lung resection).;Timepoint(s) of evaluation of this end point: Four to six hours after the study drug administration

Secondary Outcome Measures