Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04309630 |
| Other study ID # |
12-92-20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
January 2024 |
| Source |
Ankara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Thoracotomy is associated with severe postoperative pain due to surgical incision, rib
retraction or resection, and intercostal nerve damage. Pain management after thoracic surgery
is extremely important for various reasons, including respiratory mechanics, decreased
atelectasis, early mobilization, decreased opioid consumption, decreased hospital stay, and
patient satisfaction.
Thoracic epidural analgesia and thoracic paravertebral blocks, although it comes to mind in
the first place for thoracic surgery, the difficulty / failure of the application technique
and the use of side effects such as spinal cord injury, pneumothorax and hypotension.
Alternative regional methods have come to the fore in recent years. Erector spina plan block
(ESPB) is a recently defined interfacial plan block used for the treatment of thoracic
neuropathic pain, trauma and acute pain after surgery.
Local anesthetic injection for ESPB can be applied both to the surface and deep into the
erector spina muscle. When local anesthetic is applied deep into the erectral spina muscle,
it has been demonstrated by the cadaver findings that the thoracic spinal nerves reach both
the dorsal and ventral ramus with the spread of the paravertebral and intercostal areas. The
thoracolumbar extension of the erector spina muscle allows wide cranio-caudal spread of
injections in this plane and analgesia involving multiple dermatomes. This multisegmental
analgesia allows ESPB to be used in pain management after thoracic or abdominal surgery.
Accompanied by ultrasound, ESPB is simple and reliable. With the easy recognition of
sonoanatomy, the risk of damage to the surrounding tissues is negligible . If necessary, a
permanent catheter can be placed that can be used to prolong analgesia time and can be used
for both intraoperative and postoperative analgesia with catheter-mediated ESPB.
Description:
After the approval of the ethics committee, patients with ASA I-II, elective thoracotomy plan
will be informed that they will be included in the study before the operation and informed
consent will be obtained. Routine preoperative anesthesia examinations of the patients will
be performed. When patients come to the operating table, after routine monitoring of ECG,
non-invasive blood pressure, pulse oximeter, BIS and TOF, sedation will be applied to
patients.
After preoxygenation is performed with oxygen flow of 4 l / min, anesthesia induction will be
applied to patients with propofol 3mg / kg and rocuronium 0.6mg / kg, and the patient will be
intubated after sufficient muscle relaxation is achieved. Maintenance of anesthesia will be
provided with BIS 40-60 with desflurane and 50% air + 50% O2. During the operation period,
patients will receive 50mcg of fentanyl per hour for intraoperative analgesia and 10mg
rocuronium to maintain muscle relaxation. At the end of the surgery, patients will be
administered IV 1gr paracetamol and 4mg ondansetron to reduce the risk of vomiting
postoperative nausea.
At the end of the surgery, thoracic vertebral spinous processes will be displayed by placing
the linear ultrasound probe in the middle line at the level of T5 vertebra under the aseptic
conditions while in the lateral decubitus position. Then, the transducer process of the
subcutaneous adipose tissue, m.trapezius, m.rhomboideus major, m.erector spina and T5
vertebra will be displayed by shifting the probe 2-3cm laterally. After the needle placement
is confirmed by hydrodissection with 3ml of 0.9% NaCl under the erector spina muscle, after
20ml 0.5% bupivacaine injection, the catheter will be placed in the 2-3cm intercostal area
and the infusion of 2-4ml / hour 0.5% bupivacaine, daily total dose 400mg will not be
exceeded. In the second group of patients, catheter will be placed in the intercostal area by
the surgical team at the end of the surgery and 2-4ml / hour 0.5% bupivacaine infusion will
be adjusted so that the total daily dose does not exceed 400mg.
After the anesthetic agent is terminated, when the TOF is 4, the effect of the muscle
relaxant will be reversed by applying neostigmine and atropine to the patients. In order to
provide analgesia to the patients in the postoperative period, the IV patient controlled
analgesia device will be prepared as bolus with a 10-minute lock time, with the total dose of
fentanyl not exceeding 1mcg / kg per hour, and will be started by explaining to the patients
in the post-surgery department. If VAS> 4 and PCA bolus is insufficient, patients will
receive paracetamol 1gr IV infusion.
Surgical procedures, incision length, operation time, total muscle relaxant and fentanyl
doses used in the intraoperative period, the amount of fluid given to the patients, the
amount of urine of the patients, the amount of bleeding during the operation, and the
patient's blood pressure, heart rate and additional drug use will be recorded in the
operation room.
Visual analogue scale (VAS) scores, satisfaction, nausea, vomiting, antiemetic use, itching
complaints, mean artery at 30 minutes, 6,12,24,48,72 hours and postoperative time of chest
withdrawal time. pressure, heart rate and saturation are monitored, the quality of the
recovery will be evaluated with ALDRETE scoring and additional analgesic needs will be
questioned. Patient controlled analgesia device will be requested at 30 minutes, 6, 12, 24
and 48 hours, and the number of bolus requested by the patient, the number of bolus delivered
to the patient and the amount of drug will be recorded.
In the postoperative 3 and 6 months, when patients come for control, it will be learned from
the patient whether they have pain, and if there is any pain, whether any procedure is
applied for this pain.
