Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05321576 |
| Other study ID # |
09.2022.100 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2022 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients with an ASA score of 3 and below, who will undergo lobectomy with video-assisted
thoracic surgery (VATS) method, and who gave informed consent will be included in this study.
Patients with contraindications for the application of either of the two methods, with known
chronic pain, opioid use, local anesthetic allergy, spinal deformity or mental or psychiatric
problems that prevent cooperation, those taking anticoagulants, and those with infection at
the injection site will not be included in the study. In addition, patients in the ESPB group
who required intraoperative opioids, patients who failed ESPB, and patients who underwent
open surgery in both groups will not be included in the analysis. Patients who agree to
participate in the study will be randomly assigned to one of the study's opioid-free
anesthesia and ESPB (erector spina plan block) (Group 1) or standard opioid (Group 2,
control) anesthesia groups. Randomization will be at the 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 at random before the procedure for each patient, and procedures will
be carried out according to the group specified on the paper.
Description:
Group 1 (opioid-free ESPB) Before induction of anesthesia, patients in this group will
undergo ultrasound guidance in a sitting position on the operating table, and an erector
spina plan block will be performed with bupivacaine and lidocaine, by entering unilaterally
(to the side to be operated) 3 cm lateral to the T5 spinous process. Under standard
monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia
induction will be performed with propofol (2 mg/kg), ketamine 2 mg/kg, and rocuronium 0.6
mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be
started immediately after intubation. Patients will not take any opioids throughout the
surgery and will be infused with dexmedetomidine instead. Dexmedetomidine infusion will be
started at a dose of 0.4 microgram/kg/hour, BIS < 50 and the dose of dexmedetomidine will be
adjusted so that ANI > 50. Patients for whom dexmedetomidine could not be sufficiently
effective and opioid use became mandatory will not be included in the analysis. Before
postoperative awakening, patients were given 1 g i.v. paracetamol will be given.
Group 2 (standard anesthesia with opioid) Under standard monitoring (ECG, non-invasive blood
pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol
(2 mg/kg), remifentanil 1 microgram/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and
analgesia nociception index (ANI) monitoring will be started immediately after intubation.
Patients will receive an infusion of remifentanil throughout the surgery. Remifentanil
infusion will be started at a dose of 0.5 microgram/kg/hour, and the dose of remifentanil
will be adjusted so that BIS < 50 and ANI > 50. Before postoperative awakening, patients were
given 1 g i.v. paracetamol will be given.
Perioperative clinical and demographic data of each patient will be collected: age, gender,
diagnosis, operation, ASA status, 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. In addition, the total intraoperative opioid
dose (Group 2) and dexmedetomidine (Group 1) dose will be recorded.
Post-awakening pain will be assessed and recorded using a 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 the required
additional analgesics (tramadol, paracetamol, etc.) will be recorded. Groups will be compared
for primary outcome measure and secondary outcome measure.
Although neuropathic pain after VATS is less than the thoracotomy approach, it can still pose
a significant postoperative problem. Pain management after VATS is especially important to
prevent respiratory complications. However, intraoperative or postoperative excess morphine
consumption will also negatively affect postoperative recovery after thoracic surgery. It has
been shown that opioid-free anesthesia can reduce the need for morphine and reduce related
complications.
In the ultrasound-guided erector spina plan block technique, which is a regional anesthesia
technique that has been defined recently, local anesthetic is injected into the erector spina
muscle and facial plane and spreads in the caudal and cranial directions. This technique has
been successfully used as a postoperative analgesia or intraoperative regional anesthesia
technique in areas such as thoracic surgery and trauma, breast surgery, abdominal surgery,
and extremity surgery. Erector spina plane block or other block methods have been mostly used
for postoperative analgesia after VATS, and they have been shown to provide effective
postoperative analgesia and reduce morphine consumption. However, data on the use of ESPB or
other block techniques for anesthesia during VATS are limited. Opioid-free anesthesia with
the help of ESPB may help recovery by reducing total and postoperative morphine consumption.
The aim of this study is to compare opioid-free anesthesia with ultrasound-guided ESPB in
patients who underwent lobectomy with VATS, with standard opioid-containing anesthesia in
terms of postoperative morphine requirement, as well as intraoperative variables,
postoperative pain management and postoperative recovery, and complications.
