Ipsilateral shoulder pain after thoracotomy for lung resection.
Conditions
Interventions
Trade Name: LIDOCAINA INYECTABLE BRAUN 2%
Product Name: LIDOCAINE
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: lidocaine
CAS Number: 137-58-6
Other descr
Sponsors
University Hospital Germans Trias i Pujol
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy end point: Proportion of patients with an ipsilateral shoulder pain VAS<3 at four hours after the end of surgery in both groups Safety end points: Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery. Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups. ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours) ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours.;Timepoint(s) of evaluation of this end point: Efficacy end point: at four hours after the end of surgery in both groups Safety end points: Median differences in CMAP´s latency and amplitude between basal measure and those measured at 1, 5 and 10 minutes after drug administration and at the end of surgery. Median differences in spirometric values (Vital forced capacity, Forced expiratory volume in 1 second and Tiffeneau Index) between pre and post-surgery (4 hours after surgery) in both groups. ?Proportion of patients with radiological ipsilateral hemidiaphragm elevation in both groups (within first 12 postoperative hours) ?Proportion of patients with pneumonia, atelectasis and/or mechanical ventilation (invasive or non-invasive) within the first 72 postoperative hours. | — |
Countries
Spain
Contacts
Public ContactThoracic Surgery Dept.
University Hospital Germans Trias i Pujol
Outcome results
None listed