Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES)
Condition: Respiration Disorders
MeSH terms: Respiration Disorders
Study type: Interventional

Summary: 
      Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was
      provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA)
      in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at
      rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours
      of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements
      were recorded
    

Detailed description: 
      lung cancer patients (between ages 18 to 75 and American Society of Anesthesiologists -ASA-
      Class I to III), undergoing an elective thoracic surgical procedure with posterolateral
      thoracotomy, were enrolled. The study was approved by the local ethical committee in Yedikule
      Chest Diseases and Thoracic Surgery Ed. and Research Hospital and therefore had been
      performed in accordance with global ethical standards. Written informed consent was received
      from all participants.

      Individuals beyond defined age limits, patients who have psychiatric problems, auditory
      deficit, drug abuse, severe cardiovascular system disorders or severe respiratory depression
      depicted as having less than 50% of the predicted value of forced expiratory volume were
      excluded. Patients refusing to give consent and to whom inserting an epidural catheter is
      contraindicated were not involved either. Surgical procedures were performed by the same
      team. In the operating room, if serratus anterior muscle could not be spared or chest wall
      resection was performed, these patients were also excluded even though they had met other
      qualifications. Finally, patients who could not be extubated before transfer were not
      involved.

      Regarding pre-operative evaluation, age, gender, weight, height, smoking status
      (package/years) and ASA score of patients were recorded.

      For assessing the impact of method of analgesia on target parameters, patients were allocated
      to TEA and intravenous analgesia (IVA) groups. Randomisation was performed by closed envelope
      method.

      2.2 Features of anesthetic technique and intraoperative analgesia Before the initiation of
      procedure, in TEA group epidural catheter was inserted by loss of resistance method at the
      level of T3-T7 with the help of a 18 G Thuohy needle (Pajunk, Geisingen, Germany) while
      patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered
      through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was
      injected. Analgesia maintanence was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour)
      both intra- and postoperatively for 24 hours.

      Anesthesia was induced with midazolam (0.04 mg/kg), propofol (2 mg/kg) and fentanyl (1mcg/kg)
      in both groups and the neuromuscular blockage was provided with cisatracurium besilate (0,2
      mg/kg). Then, insertion of a double-lumen tracheal tube was performed. After standard patient
      positioning, localization of the tube was checked with a fiberoptic bronchoscope. Pressure
      controlled ventilation was used (Primius, Drager, Luebeck, Germany) and invasive arterial
      pressure, electrocardiography, arterial blood gas analysis, end-tidal carbon dioxide
      concentration, central venous pressure and urine output were closely monitored in the
      operating room. Hypothermia was avoided with the help of a warming system and body
      temperature was kept over 36°C. In TEA group, absolute intraoperative analgesia was warranted
      with 0,5-2 MAC sevoflurane. In IVA group, remifentanyl infusion (0.1-0.2 mcg/kg/min) was
      additionally used for this purpose. If arterial pressure exceeds a value of 20% or more of
      baseline recordings, 1 mcg/kg fentanyl was administered. Every one hour, an additional dose
      (0.25 mg/kg) of cisatracurium besilate was administered to ensure complete myorelaxation.

      The intercostal blockage was applied by the surgical team to the entire population before
      closing the wound by injecting 4 ml of 0.25% bupivacaine to the region of incision and two
      intercostal regions above and below the incision site. Once closure was started, morphine
      sulphate (0,1 mg/kg), tramadol (100 mg), paracetamol (100 mg) and tenoxicam (20 mg) was given
      intravenously. Anterior 28 Ch and posterior 32 Ch drainage tubes were inserted to the
      patients to whom lobectomy or bilobectomy was performed. For pneumectomy, only posterior 32
      Ch tube was placed. After reversal of neuromuscular blocking agents, patients with adequate
      spontaneous ventilation and verbal response were transferred to the critical care unit.

      Regarding to peri-operative data, procedure time, type of the operation (lobectomy or
      pneumectomy), duration of tube drainage and presence of operation related complications were
      recorded.

      Visual Analogue Score (VAS) was used to estimate the severity of pain. A score of 0 cm
      represented "no pain at all" and 10 cm did "intractable pain" so.
    

Intervention name(s): Thoracic epidural analgesia; Bupivacaine
Intervention type(s): Procedure; Drug
Intervention description(s): Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.; In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.
Other intervention name(s): Posterolateral thorachotomy; Intercostal blockade; Pethidine intravenous infusion
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Blood gas analysis; Epidural analgesia; Lung cancer; Respiratory function tests; Thoracotomy