Video-assisted Thoracoscopic Surgery Clinical Trial
Official title:
Patient-Controlled Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Thoracic surgery is commonly associated with severe postoperative pain and marked impairment
of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is
assumed to result in better quality of life and less postoperative pain compared with
standard open thoracotomy, other investigators have reported comparable patient-reported
physical component summary and pain scores after VATS and thoracotomy during the first 12
months after lung resection.2 That study was non-randomized and 41% of the included patients
did not complete the follow-up period.2 VATS has recently been increasing in popularity as a
fast-track surgery with potential enhanced recovery after surgery.
Variety of approaches exist to manage pain after thoracotomy which could attenuate
post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many
decades to be the best method of pain relief after major thoracic surgery. In previous
meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB)
has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing
thoracotomy.
Additionally, PVB has a better side-effect profile, lower rates of failed block and is
associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to
enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7
Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative
analgesia, that allows a perfect match between intensity of pain and analgesic delivery,
improves the quality of analgesia and decreases the cumulative analgesic consumption.
Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background
infusion during labour gave patients a sense of control over their analgesia, reduced the
total dose of local anesthetic administered, and had less motor block than those who receive
continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become
increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary
study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery
with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a
comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have
reported comparable analgesia after thoracic surgery with the use of either
patient-controlled PVB had with the use of intrathecal morphine, that study was not
controlled and included few patients.14
The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of
postoperative analgesia and pulmonary function after VATS has not yet been studied.
We hypothesizes that the use of patient-controlled paravertebral blockade (PC-PVB) after VATS
will be associated with lower pain scores and less pulmonary dysfunction than continuous
paravertebral blockade (PVB).
Following obtaining of the Local Ethics Committee approval and informed patient consent, 62
patients, aged 18 -70 years, American Society of Anesthesiologists (ASA) physical status
II-III, undergoing elective VATS using postoperative thoracic paravertebral analgesia will be
included in this prospective, randomized, controlled, double-blind study.
Before operation, forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and
peak expiratory flow rate (PEFR), were measured. On the morning before surgery, the patients
will be instructed in the use of the PCA pump and a VAS. The patients will be asked to rate
their experienced pain using the VAS from 0 to 100 mm with 0 representing no pain and 100
representing the worst imaginable pain.
Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors
includes electrocardiograph, non-invasive blood pressure, and pulse oximeter. All patients
will be premedicated with iv midazolam 0.01-0.03 mg kg-1.
Before the induction of general anesthesia, paravertebral space ipsilateral to the
thoracostomy will be identified 3 cm lateral to the spinous process of T5-8 with
ultrasound-guidance (USG) using a high-frequency linear array probe of a Sonosite MTurbo
ultrasound machine (MicroMaxxs ultrasound system, Sonosite Inc, Bothell, WA). After the probe
was placed at the level of the T5-6 interspace, the apex of the paravertebral space will be
visualized as a wedge-shaped hypoechoic space surrounded by the hyperechoic line of the
pleura below and the internal intercostal membrane above. An 18 G Tuohy needle (B. Braun,
Germany) will be inserted in a lateral-to-medial direction using an in-plane approach and
will be kept advancing until the needle tip penetrates the internal intercostal membrane.7 A
20-G epidural catheter (B. Braun, Germany) will be introduced through Tuohy needle and
advanced 3 cm into the paravertebral space. After gentle aspiration, a test dose of 3 mL of
bupivacaine 0.25% with epinephrine 5 µg mL-1 will be administered through the catheter. If no
significant rise in heart rate or arterial pressure will be observed, a bolus of 0.3 mL kg-1
of bupivacaine 0.25% with epinephrine (5 µg mL-1), followed by continuous paravertebral
infusion of bupivacaine 0.25% and fentanyl 2 µg mL-1 at 0.1 mL kg-1 h-1 intraoperatively.15
In all patients, standard monitors and state and response entropy (SE and RE, respectively,
GE Healthcare, Helsinki, Finland) based-depth of anesthesia will be applied. The radial
artery will be catheterized. Anesthetic technique will be standardized in all studied
patients. After preoxygenation, general anesthesia will be induced with propofol 1.5-3 mg
kg-1 and target-controlled infusion (TCI) of remifentanil at an effect-site concentration
(Ce) of 4 ng mL-1, to achieve the SE values below 50 and the difference between RE and SE
below 10. Rocuronium (0.5 mg kg-1) will be given to facilitate the endobronchial intubation
with a left-double lumen endobronchial tube and the correct position of its tip will be
confirmed with a fiberoptic bronchoscope.
Anaesthesia will be maintained with 0.7-1.5 minimum alveolar concentration of sevoflurane and
remifentanil Ce of 2-4 ng mL-1 to maintain the SE values below 50, the difference between RE
and SE below 10 and the mean arterial blood pressure (MAP) and heart rate <20% of baseline
values. Rocuronium increments will be used to maintain surgical relaxation.
Two lung ventilation (TLV) will be instituted using fraction of inspired oxygen (FiO2) of 0.4
in air, tidal volume (VT) of 8 mL kg-1, inspiratory to expiratory (I: E) ratio of 1:2.5 and
PEEP of 5 cm H2O, and respiratory rate will be adjusted to achieve an arterial carbon dioxide
tension (PaCO2) of 4.7-6 kPa. During one-lung ventilation (OLV), the dependent lung will be
ventilated with a FiO2 of 1.0, VT of 6 mL kg-1 and I: E ratio, PEEP, and respiratory rate,
will be maintained as during TLV. The dependent lung will be recruited at 30-minute intervals
by increasing the inspiratory pressure to 40 cmH2O for 10 seconds.
All surgical procedures will be performed by the same surgeons who will be blinded for the
study group. The VATS procedure will begin with the exploration of the pleural cavity using a
30° video thoracoscopic camera through 1.5 cm single skin incision with the use of 1-3
trocars which enables the thoracoscopic instruments to move the lung.
At the end of surgery, the nondependent lung will be re-expanded, the remifentanil and
sevoflurane will be discontinued after chest closure and skin closure, respectively, and the
residual neuromuscular blockade will be antagonized.
During working hours of the first 48 hours, the patients will be visited by an acute pain
nurse and/or a consultant anesthesiologist, who will interview each patient regarding
satisfaction with postoperative analgesia. After hours, an anesthetic registrar will be
available to review analgesia management. All patients will receive multimodal analgesia
consisting of regular IV paracetamol (1 g four times a day) and IV lornoxicam (8 mg two times
a day) for postoperative pain relief.
Breakthrough pain, defined as pain VAS > 30 mm, will be treated with a bolus of 0.1 mL kg-1
of paravertebral medication administered through the pump. No additional medication will be
given if the pain VAS < 30 mm. If after 15 minutes pain VAS persists greater than 30,
additional 0.1 mL kg-1 of the paravertebral medication will be given. If the patient still
has a pain VAS > 30 despite breakthrough pain intervention, then the patient will be
connected to PCA with intravenous morphine 1 mg, with a lockout interval of 8 minutes and a
maximum 4-hourly limit of 30 mg.5
;
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