Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05618210 |
| Other study ID # |
09.2022.756 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2022 |
| Est. completion date |
May 15, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of
postoperative pain management, postoperative opioid consumption and complications in patients
undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed
consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in
this study. Patients with contraindications for the application of either method, known
chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems
that prevent cooperation, taking anticoagulants, and infection at the injection site will not
be included in the study. Patients who agree to participate in the study will be randomly
assigned to one of the anesthesia groups of the study, which include ESPB (elector spina
plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1
and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of
one of the two groups will be placed inside the envelopes and the envelopes will be closed
and mixed. A closed envelope will be drawn randomly for each patient before the procedure,
and procedures will be carried out according to the group specified on the paper.
Description:
Video-assisted thoracic surgery (VATS); Although it causes less postoperative pain compared
to traditional thoracotomy, it can still cause significant postoperative problems. Relief of
postoperative pain; it eliminates the undesirable pathological effects of pain, reduces the
length of hospital stay and costs. Thoracic epidural analgesia and paravertebral block are
recommended for the relief of postoperative pain after thoracotomy. Bendixen et al. Because
VATS is less painful; recommended less invasive regional techniques and systemic analgesics.
For the relief of postoperative pain after VATS; paravertebral block, erector spina plan
block (ESPB), and serratus plan block have been successfully applied. In order to provide
analgesia after VATS; the most appropriate techniques or protocols need to be determined.
ESPB; In 2016, Forero et al. and is used for the control of pain after many surgical
procedures. ESPB has been successfully applied for the relief of postoperative pain after
VATS. Elsharkawy et al. have shown that rhomboid intercostal block can be beneficial in
providing adequate analgesia for both anterior and posterior hemithorax, in cadaver studies,
but it is better with methods that are useful in relieving pain after VATS previously. They
say more comparisons are needed. In recent studies, it has been shown that rhomboid
intercostal block is effective in relieving postoperative pain in comparison with control
groups. More randomized controlled studies are needed to demonstrate that rhomboid
intercostal block provides effective analgesia in VATS. The aim of this study is to compare
ultrasound-guided ESBP and Rhomboid block in terms of postoperative pain management,
postoperative opioid consumption and complications in patients undergoing lobectomy with
VATS.
The aim of this study is to compare ultrasound-guided ESBP and Rhomboid block in terms of
postoperative pain management, postoperative opioid consumption and complications in patients
undergoing lobectomy with VATS.Patients aged 18-75 years, ASA 1-2-3, who gave informed
consent to lobectomy with video-assisted thoracic surgery (VATS) method will be included in
this study. Patients with contraindications for the application of either method, known
chronic pain, local anesthetic allergy, spinal deformity or mental or psychiatric problems
that prevent cooperation, taking anticoagulants, and infection at the injection site will not
be included in the study. Patients who agree to participate in the study will be randomly
assigned to one of the anesthesia groups of the study, which include ESPB (elector spina
plane block) (Group 1) or Rhomboid block (Group 2). Randomization will be at a ratio of 1:1
and will be done by the closed-envelope method. Beforehand, a piece of paper with the name of
one of the two groups will be placed inside the envelopes and the envelopes will be closed
and mixed. A closed envelope will be drawn randomly for each patient before the procedure,
and procedures will be carried out according to the group specified on the paper.
Intraoperative anesthesia management The patients in this group were on the operating table
before induction of anesthesia, and in the ESPB group (Group 1), after the patients were
placed in the prone position, the linear ultrasound probe was placed in the midline in the
transverse plane, and spinous processes were visualized at the T5 vertebra level, and the
transverse process, trapezius, latissimus dorsi and erector spina muscles were visualized on
the side where VATS was planned. will be displayed. With an 'in-plane' approach, using a 22
gauge 5-8 cm block needle with extension line (Braun, Melsungen, Germany), which can be seen
on ultrasound, the skin, subcutaneous and trapezius, latissimus dorsi and erector spina
muscles are passed in the cranio-caudal direction and 0.5- After confirming the needle site
with 1 ml of saline, the ESPB will be administered with 20 ml of 0.5% bupivacaine by
visualizing the local anesthetic spread linearly.
In the rhomboid intercostal block group (Group 2), after the patients are placed in the prone
position, the ipsilateral arm is positioned towards the chest, allowing the scapula to move
laterally and the area called auscultation triangle to be opened, and after the skin
disinfection of the surgical side; By using a linear ultrasound probe, the rhomboid major and
intercostal muscles will be defined in the auscultation triangle region, and a 50-80 mm
needle will be injected into the plan between them at the T5-6 level with an in-plane
approach with 20 ml of 0.5% bupivacaine and local anesthetic injection.
Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation),
anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and
rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring
will be started immediately after intubation. Anesthesia will be maintained with remifentanil
infusion, with ANI > 50 and BIS < 50. Patients were given 1 g i.v. before waking up after
surgery. paracetamol will be given. Measurements Perioperative clinical and demographic data
of each patient will be collected: age, gender, diagnosis, operation, ASA, duration of
surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS
measurements will be made and recorded in all patients at 15-minute intervals. The total
intraoperative opioid dose will also be recorded.
Post-awakening pain will be assessed and recorded using the visual analog scale (VAS), then
patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes
and given 4 mg of morphine at each application by the patient. Pain assessment will be done
with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount
of morphine administered by PCA (in the first and second 24 hours) and any additional
analgesics required (tramadol, paracetamol, etc.) will be recorded.
sample size In a previous study, based on the consumption of morphine equivalent in the first
24 hours (approximately 2.75 mg standard deviation) [8], it was found that 33 patients per
group were required to detect the 2.5 mg difference between the two groups with 90% power and
5% alpha error. . Considering that there may be a dropout of approximately 10 percent, it is
planned to include at least 35 patients in each group.
Statistical analysis In the comparison of the two groups in terms of continuous numerical
variables, Student t test or Mann-Whitney U test will be used for independent samples
according to distribution. Groups will be compared in terms of categorical variables using
the Pearson chi-square test or the Fisher exact test. Two-way ANOVA test will be used for
repeated measurements in comparison of groups in terms of the course of postoperative VAS
scores and intraoperative heart rate, blood pressure, ANI, BIS variables over time. A value
of p<0.05 will be accepted as an indicator of significance in the tests.
