Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05483647 |
Other study ID # |
LNMY-FPGE- ANESTHESIOLOGY-TPED |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
July 5, 2022 |
Study information
Verified date |
August 2022 |
Source |
Lviv National Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The main aim of our study was to test the hypothesis that Erector spine plane block (ESP)
with sedation will provide the similar employment of fentanyl and propofol during surgery as
an infiltrative local anaesthesia with sedation. The primary endpoint was the quantity of
fentanyl and propofol during surgery.
Description:
Primary outcome: amount of fentanyl and propofol during surgery. Secondary outcomes: adverse
events during sedation using World Society of Intravenous Anaesthesia (SIVA) adverse sedation
event reporting tool [15], level of postoperative sedation with Richmond Agitation-Sedation
Scale (RASS), intensity of pain after surgery using a visual analogue scale (VAS), the
mechanical pain threshold (MPT) with von Frey monofilaments measured on both lower
extremities, satisfaction with analgesia using 5-point Likert scale.
In both groups, intraoperative analgesia was provided by fentanyl, intraoperative sedation by
propofol. Fentanyl was administered to the patients of booth groups in the case of low back
pain complaint and/or increasing in heart rate and blood pressure more than 20% of baseline
in the dose of 50 μg. If case of sharp shooting pain in lower extremity the surgeon changed
the position of the endoscope in order not to irritate the spinal cord root, fentanyl was not
administrated.
After performing the local infiltrative anaesthesia or ESP, propofol was given by
target-controlled infusion based on the propofol pharmacokinetic parameters reported by
Eleveld 2.1 [16]. The initial propofol plasma concentration target was 1,0 μg ml-1 in both
groups (we used iTIVA plus Anaesthesia software v5.2.3 to predict the propofol
concentrations). Subsequently, the infusion rate of propofol was changed in order to reach
not less than 2-3 score levels of modified observer's assessment of alertness/sedation scale
(MOAA/S).
During procedural sedation was used World SIVA adverse sedation event reporting tool. All
five steps which require this tool were completed. If there were one or more adverse events
associated with this sedation encounter (minimal risk descriptors, minor risk descriptors,
sentinel risk descriptors or other) they were described. Interventions that were performed to
treat the adverse events and the outcomes of the adverse events were also noted.
After the discharge from the operating room to postoperative ward, the level of postoperative
sedation was accessed using RASS. Two hours after surgery intensity of pain and the
mechanical pain threshold were obtained as well as satisfaction with analgesia using 5-point
Likert scale.
To determine the mechanical pain threshold after surgery Von Frey monofilaments were used.
The set consists of 20 nylon filaments of different thicknesses in ascending order. Patients
were asked to lie down on their backs, close their eyes and inform the doctor when they felt
a clear point of contact with the skin. Monofilaments were pressed against the skin of the
middle third of the palmar surface of the forearm at an angle of 90 ° until the filament
bends for 2 seconds. Monofilaments were used in ascending order with an interval of 10
seconds.
All patients in the operating room received paracetamol, dexketoprofen, ondansetron,
dexamethasone, and tranexamic acid. In prone position, before the skin incision, patients in
G1 underwent local infiltrative anaesthesia et the level of incision. The skin, subcutaneous
tissue and muscles up to the foramen intervertebral were anesthetized by the surgeon
employing forty millilitre solution of Lidocaine 1% with Dexamethasone 0.02% and Epinephrine
0.00018%. Patients in G2 underwent bilateral ESP. The transverse vertebral process of the
required level of spine was identified using the mobile C-arm X-ray System. When the tip of
the 22G needle reached to the transverse vertebral process 3 cm lateral to the spinous
process, a solution of 40 millilitres of Lidocaine 1% with Dexamethasone 0.02% and
Epinephrine 0.00018% was injected under the erector spinae muscle bilaterally. For
postoperative analgesia, patients in both groups received nonsteroidal anti-inflammatory
drugs (paracetamol in combination with dexketoprofen) every six hours. Thromboprophylaxis was
administered based on the risk of thromboembolic complications.
Duration of observation of the patients was proceed until discharge from the hospital.